Qualification File - Associate - Regulatory Affairs and Intellectual Property (IVD and Medical Devices)

Qualification Code
NSQF Qualification File

Approved in 21st NSQC, dated- 28/07/22 QM-05-LS-00253-2023-V1.1-LSSSDC
Rationalized on file 20.03.2023
CONTACT DETAILS OF THE BODY SUBMITTING THE QUALIFICATION FILE
Name and address of submitting body:

Life Sciences Sector Skill Development Council
14, Palam Marg, Rear 2nd Floor, Vasant Vihar, New Delhi, PIN 110057
Phone: +91 11 41042407/ 408, E-mail: info@lsssdc.in
Name and contact details of individual dealing with the submission

Name: Mr. Anshul Saxena
Position in the organisation: Senior Director
Address if different from above:
Same as above
Tel number(s): + 91 11 41042407/ 408, +91 9650433002
E-mail address: anshul.saxena@lsssdc.in
List of documents submitted in support of the Qualifications File

1 Qualifications Pack
2 LSSSDC Protocol for Accreditation of Assessment Agencies and Assessment
Guidelines
3 Minutes of meeting of Governing Body
● Composition of National Committee of NOS
4 NSDC Sector Skill Gap Report for Life Sciences Sector is available at
http://nsdcindia.org/sites/default/files/files/Pharmaceuticals.pdf
5 Occupational Map and Career Progression Map
6 List of companies and Industry associations participated in the development of
these qualification
7 List of qualification /NOS validating companies
Model Curriculum (attached as annexure) including the following:

•Indicative list of tools/equipment to conduct the training
•Trainers & Assessor qualification
•Unit Plan with Learning Objective
•Distribution of training duration into theory/skill practical/Project and Viva
component
NSQC Approved 1
Approved in 21st NSQC, dated- 28/07/22
SUMMARY
1 Qualification Title Associate- Regulatory Affairs and
Intellectual Property (IVD and Medical
Devices)
Options:
1. Regulated Business Operations =60
Hours
2 Qualification Code, if any LFS/Q0513, Ver. 2.0
3 NCO code and occupation NCO-2015/3359
NCO-2015/2611.1001
Research and Development

4 Nature and purpose of the Short term training with or without
qualification (Please specify apprenticeship, embedded Higher
whether qualification is short term Education Programs and
or long term) Elective Subject in B. Pharma. 8th Sem
For Future Skills
5 Body/bodies which will award the Life Sciences Sector Skill Development
qualification Council
6 Body which will accredit providers Life Sciences Sector Skill Development
to offer courses leading to the Council
qualification
7 Whether Yes, attached the copy as annexure 1
accreditation/affiliation norms are
already in place or not, if
applicable (if yes, attach a
copy)
8 Occupation(s) to which the Research and Development
qualification gives access
9 Job description of the occupation Associate- Regulatory Affairs and
Intellectual Property (IVD and Medical
Devices) prepares dossiers to support
appropriate licensing, marketing and
legal compliance of products and
ensure products comply with current
regulations. The job role holder carries
out proper documentation and reporting
for dossier preparation and assist in
intellectual property management.
10 Licensing requirements Not applicable
NSQC Approved 2
11 Statutory and Regulatory Nil
requirement of the relevant sector
(documentary evidence to be
provided)
12 Level of the qualification in the 5
NSQF
13 Anticipated volume of Compulsory Notional Hours
training/learning required to Theory=180 Hours
complete the qualification Practical= 330 Hours
Employability skills=90 Hours
Total Compulsory Notional Hours=600
Hours
Total Notional Hours =600 Hours
Notional Hours for Optional Module

Theory= 30 Hours
Practical= 30 Hours
Total Notional Hours for Optional
Module= 60 Hours
Min Notional Hours: 600 Hours

Max Notional Hours with 1 Option:
660 Hours
Recommended Apprenticeship
Duration=6 months
14 Indicative list of training tools Attached as annexure 2

required to deliver this qualification
15 Entry requirements and/or B. Tech Final Year Student (in Relevant

recommendations and minimum Field)
age OR
B. Pharma final year student
OR
M. Sc (with relevant Subjects) Final
Year Student
Min Age: 21 Years
NSQC Approved 3
16 Progression from the qualification Vertical progression
(Please show Professional and 1. Specialist- Quality Assurance
academic progression) (Pharma, Biological Products and
Medical Devices)
Lateral/Horizontal progression
1. Associate- Regulatory Affair &
Intellectual Property (Level 5)
17 Arrangements for the The process to award the qualification
Recognition of Prior Learning (RPL) via RPL mode and detailed
methodology is given in point No.22
18 International comparability While preparing the NOSs, a detailed
Whether known (research evidence secondary desk research was
to be provided) conducted. The European, South
African and Australian NOSs were
referred to. The relevant International
NOSs for the job role are listed below
for reference:
UK NOS
● COGPACK21 Produce by
process operation
● COGPACK44 work effectively in
a team
● COGPIO1.3 prepare process
materials
● COGPIO2.15 identify and deal
with industry hazards
● COGPIO3.2 control emergencies
● SFHPHARM23 check
documentation and materials
● SKSPI25 Mix, store and manage
processing chemistry
● COGLS201 Follow health and
safety procedures in life sciences
● COGLS301 Maintain health and
safety in life sciences
Switzerland NOS
● Refer page no. 190 International
Standard Classification of
Occupations ILO Geneva
NSQC Approved 4
Australia NOS
● Apply 5S procedures in a
manufacturing environment
● Apply Good Manufacturing
Practice procedures
● Follow work procedures to
maintain Good Manufacturing
Practice
● Operate a production process
● Participate in OHS processes
● Participate in work teams and
groups
South Africa NOS

● Act in accordance with ethical
and legal codes of
pharmaceutical representation
and the laws of the country
● Manufacture pharmaceutical
products on a large scale
● Weigh raw materials in large
scale pharmaceutical
manufacturing
19 Date of planned review of the 28/July/2025
qualification
20 Formal structure of the qualification
Mandatory Components
NOS/ Module Details Total Level Credit
Duration
Hours
Compulsory Bridge Module 30:00 Level-5 1.00

Introduction to life sciences industry
and applicable regulations &
Fundamentals of Research and
Development in medical devices and
In-vitro Diagnostic Devices (IVD)
Compulsory Module 120:00 Level-5 4.00
LFS/N0570 v2.0: Development of
Technical Dossier as per the
regulatory guidelines of intended
market (India and Global) for medical
NSQC Approved 5
devices and In-vitro Diagnostic
Devices (IVD)
LFS/N0502 v3.0: Submission of
Technical Dossier as per the
regulatory guidelines
LFS/N0569 v2.0: Assist in managing
the regulatory affairs for medical
devices and In-vitro Diagnostic
Devices (IVD)
LFS/N0571 v2.0: Assist in intellectual
property rights management for life
sciences products and assets
LFS/N0567 v2.0: Coordinate with
Manager, team-members, cross-
functional teams and auditors
LFS/N0122 v2.0: Ensure adherence to
Environment, health and safety
guidelines at workplace by self and
subordinates
DGT/VSQ/N0103: Employability Skills 90:00 3.00
Total Duration (A) 600:00 20.00
Optional Components
NOS/ Module Details Total Level

Duration
Hours
Option 1 : Regulated Business 30:00 Level-5 1.00
Operations
LFS/N0120 v2.0: Establish own
enterprise and perform various
entrepreneurial activities to run the
business operations in Life Sciences
Sector
Option 1 : Regulated Business 30:00 Level-5 1.00
Operations
NSQC Approved 6
LFS/N0121 v2.0: Maintain the critical
business documents as Entrepreneur
in Life Sciences Sector
Sub Total Duration (Hours) (B) 60:00 2.00
Total Maximum Duration of Notional Hours 660:00

(A+B)
Apprenticeship Component
Recommended Apprenticeship Duration 6 Months
SECTION 1
ASSESSMENT
21 Body/Bodies which will carry out assessment:
Following assessment agencies will carry out assessments:
1. Induslynk Training Services Pvt. Ltd.- Mercer- Mettl, 7&8th Floor, SN 1&2, Good
Earth Business Bay, Sector 58, Gurugram, 122101
2. SHL (India) Pvt. Ltd.- 6-Tower-B, 10, DLF Building, DLF Cyber City, Gurugram,
Haryana, 122002
3. Cleveratti Skill Pvt. Ltd.- 3704, DLF Phase IV, Near Galleria Market, Gurugram
122002, Haryana
22 How will RPL assessment be managed and who will carry it out?
Assessment process for RPL programs (Candidates with experience in the

occupation or for informally trained and employed trainees):
● Every RPL batch is uploaded on Skill Development Management System (SDMS)
managed by National Skill Development Corporation (NSDC). SDMS reflects the
proposed date of assessment for the batch. The batch is uploaded on SDMS by
RPL project implementation agency.
● LSSSDC conducts Assessments via its empanelled Assessment Agencies and
assigns the batch to an assessment agency pre-notified with NSQC for the job
role.
● Assessment agency ensures the availability of required infrastructure, tools for
the assessment.
● Assessments for RPL candidates are conducted in following two modes:
A) Theory and Skill Practical on a fully digital platform.
B) Theory part digital and practical part through actual assessor observation.
NSQC Approved 7
● The authenticity of Trainee’s identity and eligibility is verified by project
implementation agency by verifying the ID proof documents (any document
issued by GOI, such as Aadhaar Card, Driving License, Passport, election card
etc.) and experience proof (industry endorsement, experience letters)
● Assessment agency collects evidences of the assessment in best possible way
(videos, pictures, assessment logs etc.)
● The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days from the date of assessment.
● LSSSDC validates the assessment results and announces the result on SDMS
within 15 days of assessment date.
● Passed candidates are provided with qualification certificate.
Assessment tools: For the Training assessment, the assessment instrument

development is done by the selected assessment body with close monitoring and
support of LSSSDC at every stage.
Digital Written test for knowledge assessment:

Scope – Is used to test the knowledge component of the Qualification.
Tools – Computer or tab based online or offline.
Method – objective type questions, match the columns, fill in the blanks, tick the odd
man out, choose the correct option, choose the best answer, True or false, Identify the
object, tool or machinery, arrange in proper sequence, case study, scenario-based
responses.
Analysis – Question paper is divided in sections. Each Section intends to assess a
particular knowledge field of the trainee. Thus, section wise calculation of marks gives
the clear idea of the areas of improvement or expertise of the trainee. While a
consolidated mark gives the overall rating of the trainee.
Digital Written test for skill assessment

Scope – Is used to test primarily the Skill component of the qualification. Trainee’s
expertise in handling and managing the situation is tested.
Tools – computer or tab based online or offline questions.
Method – A situation is narrated or created in the question posed to the trainee and he
is asked objective type questions to select the correct reaction to the situation. The
selected situations are based on real situations.
particular skill field of the trainee. Thus, section wise calculation of marks gives the
clear idea of the areas of improvement or expertise of the trainee. While a consolidated
mark gives the overall rating of the trainee.
Following assessment agencies will carry out assessments:
NSQC Approved 8
1. Induslynk Training Services Pvt. Ltd.- Mercer- Mettl, 7&8th Floor, SN 1&2, Good
Earth Business Bay, Sector 58, Gurugram, 122101
2. SHL (India) Pvt. Ltd.- 6-Tower-B, 10, DLF Building, DLF Cyber City, Gurugram,
Haryana, 122002
3. Cleveratti Skill Pvt. Ltd.- 3704, DLF Phase IV, Near Galleria Market, Gurugram
122002, Haryana
23 Describe the overall assessment strategy and specific arrangements which have
been put in place to ensure that assessment is always valid, reliable and fair and
show that these are in line with the requirements of the NSQF.
Assessment Agencies: An assessment agency is selected based on

● Prior experience and understanding of Life Sciences or similar sector.
● Experience in conducting assessments for similar job roles.
● Manpower and Technical capabilities.
● Geographical reach
● Existing Network in the Life Sciences Sector
● Agency’s internal policies to maintain Standards, Quality & professional Integrity
● Agency’s policy in assessor management
Assessment development: The assessment development is done with close

monitoring and under supervision of LSSSDC at every stage.
Steps for assessment development:
● Selection of assessment tool(s) is done as per the assessment criteria
prescribed in Qualification.
● For Associate- Regulatory Affairs and Intellectual Property (IVD and Medical
Devices) assessment a blue print of the question paper, is part of assessment
tool for training.
● Development of lay-out of Question paper is such that the entire PCs
(Performance Criteria) of that qualification are covered.
● Score per question maps with the weightage given to that PC, in the
assessment criteria and the level of difficulty of the question.
● An expert from industry is selected who is called “Subject Matter Expert” (SME).
This SME must have over 13-15 years of experience in the industry in R&D
occupation.
● SME is screened and approved by LSSSDC. He is the oriented by both
LSSSDC and Assessment agency on – creating question Bank, level of
questions, end desired outcome of the assessment.
Assessor: The Assessors are engaged to conduct the assessments.Assessor

guidelines are followed as below:
NSQC Approved 9
Assessor Requirements
Assessor Prerequisites
Minimum Specializati Relevant Industry Training/Assessm Remark
Educational on Experience ent Experience s
Qualificatio Year Specializati Year Specializati
n s on s on
Graduate B.Pharma 6 Regulatory 2 On the job

OR Affairs and assessment/
B.E./B.Tech Intellectual Training
(with Property experience/
relevant management Vocational
subjects) of IVD and assessment/
Medical Academic
Devices assessment
M.Pharma 4 Regulatory 2 On the job

Post OR Affairs and assessment/
Graduate M.Sc Intellectual Training
(Chemistry) Property experience/
OR management Vocational
M.E./M.Tech of IVD and assessment/
(with Medical Academic
relevant Devices assessment
subjects)
Assessor Certification
Domain Certification Platform Certification
Certified for Job Role: “Associate- Recommended that the Assessor is
Regulatory Affairs and Intellectual certified for the Job Role: “Assessor
Property (IVD and Medical Devices)”. (VET and Skills)”, mapped to the
“LFS/Q0513, v2.0” with minimum Qualification: “MEP/Q2701, v2.0” with
accepted score of 80%. minimum score of 80%.
Assessment process for fresh skill development programs (Short term without
apprenticeship):
● Every fresh batch is uploaded on Skill Development Management System
(SDMS) managed by National Skill Development Corporation (NSDC). SDMS
reflects the Start date, end date of the training and date of assessment for the
batch. The batch is uploaded on SDMS by Vocational Training Centre.
NSQC Approved 10
● LSSSDC conducts Assessments via its empaneled Assessment Agencies and
assigns the batch to an assessment agency pre-notified with NSQC for the job
role.
the assessment.
● Assessments for Fresh candidates are conducted in mode of Theory and Viva for
Skill Practical. Skill Viva is conducted by an Assessor.
● In case an assessor is involved in the assessment methodology, the trainees are
scheduled in such a way that an assessor shall not assess more than 30
candidates in a day.
● Assessor and proctor from Assessment agency are present on the day of
assessment to manage the process at assessment location.
● The assessor carry Aadhaar card and which has been pre informed to the
vocational training center.
● Assessor ensures authenticity of Trainee’s identity by verifying the documents
(any document issued by GOI, such as Aadhar Card, Driving License, Passport,
election card etc.)
● Assessor collects evidences of the assessment in best possible way (videos,
pictures etc.)
● Proctor maintains the records of attendance, verified documents, and whatever
other evidence of assessment as applicable.
● Assessor maintains complete confidentiality of the score, compiles the data and
document and sends it to assessment agency.
● In cases where 100% digital assessment methodology is used, the above
verifications and document collection and maintenance is done by the proctor.
● The assessment agency after processing the results and putting them in standard
format hands over to LSSSDC within 7 days from the date of assessment.
● LSSSDC validates the assessment results and announces the result on SDMS
within 15 days of assessment date.
● Passed candidates are provided with qualification certificate.
Assessment tools: Assessment tools for a qualification are decided based on

composition of knowledge and skill in that qualification. All assessments shall have at
least two tools unless indicated otherwise. All assessments carry time allotment
required per trainee, within which the assessment should be completed.
Digital Written test for knowledge assessment:

Scope – Is used to test the knowledge component of the Qualification.
responses.
NSQC Approved 11
Digital Written test for skill assessment

Tools – computer or tab based online or offline questions.
Assessment process for Apprenticeship linked fresh skill development

programs (Short term with apprenticeship):
The assessment for the Basic Training and On the Job Training will be conducted
toward the end of the OJT duration.
Assessment Process:
The assessment will be in two parts as below:
Part 1: OJT Assessment

For OJT assessment the Industry nominated assessor will be assessing the candidates
based on the OJT monitoring report submitted by Industry supervisor and Viva by the
Industry nominated assessor
1.1 Industry nominated aassessor:

The Assessors are engaged to conduct the assessments by Industry. The selection
takes place as follows
● Industry defines the criteria for profile of an assessor.
● Assessor is a person who is currently working in the same industry on same or
higher job role and has minimum 5-7 years of experience.
● Once selected, the assessor is oriented by Industry using LSSSDC guidelines
on various aspects of the assessment and management of assessment, such as
● qualification and its background.
● Training on Assessment methodology and how to use Assessment tools.
Scoring system. (as per the attached assessment guide)
● Maintain integrity at the assessment site.
● Crisis handling and support system available for the same.
● Scope of his authorities
NSQC Approved 12
● Administrative responsibilities.
● Required documentation of Trainee credentials, mark sheet management.
● Confidentiality management.
1.2 Assessment Tool for OJT:
1.2.1 OJT Monitoring Report:

● As in Life Sciences Sector reproducing the evidence for assessment is not
feasible due to constraints like cost, confidentiality and controlled environment,
every apprentice is required to record the evidences performed during the OJT
and the same gets authorized by his/her supervisor.
● The evidence recording is done in a structured monitoring report, termed as OJT
monitoring report.
● During the OJT, every trainee is required to fill the OJT monitoring report which
is required to be signed by his/her supervisor.
● Towards the end of OJT period these reports are submitted with the HR
department of company
● These duly submitted reports are then verified by an Industry nominated
assessor for verification of evidence.
1.2.2 Viva:
Scope – Is used to test the knowledge and understanding and skills acquired during
the OJT as well as to conform the OJT monitoring report.
Some personality traits and generic skills (such as – promptness, sharpness,
communication skills, depth of knowledge, comprehension, presentation, patience etc)
can also be tested required for the qualification.
Tools – Direct dialogue between assessor and Trainee.
Method – Direct questions open and close ended questions, situation-based

questions, analytical questions, and decision-making based questions. Different
questions are included to test relevant PCs from the qualification
Analysis – Assessor draws a spectrum of ready answers to be expected from trainee.

This reduces effect of subjectivity of the assessor. Comparative quality of trainees with
in a batch or different institutes can be gauged.
1.3 Execution of OJT Assessment:

● HR department then hands over the individual OJT monitoring report with
Industry nominated assessor and schedules an assessment meeting for each
trainee
● Industry nominated assessor assesses each trainee based on OJT monitoring
report, viva on each PC and attendance with each trainee towards the end of
the OJT period.
NSQC Approved 13
● The OJT marks are compiled for each NOS by the Industry nominated assessor
and submitted with HR department of company.
● The OJT assessment results are then sent to LSSSDC by HR department of
company in a sealed envelope for compiling the assessment results.
Part 2: Basic Training Assessment

For Execution of the assessment for basic training, LSSSDC will be engaging more
than one assessment agencies/ body.
2.1 Criteria of selection of assessment body/agency:
The assessment body/agency is selected on the basis of
● Prior experience and understanding of Life Sciences or similar sector
● Experience in conducting assessments for similar job roles
● Manpower and Technical capabilities
● Geographical reach
● Existing Network in the Life Sciences Sector
● Agencies internal policies to maintain standards, quality & professional Integrity
● Agencies policy in assessor management
2.2 Assessment tool for Basic Training:

For the Basic training assessment, the assessment instrument development is done by
the selected assessment body with close monitoring and support of LSSSDC at every
stage.
2.2.1 Digital Written test for knowledge assessment:

Scope – Is used to test the knowledge component of the qualification.
Tools –computer or tab based online or offline.
responses.

2.2.2 Digital Written test for skill assessment:

Tools – computer or tab based online or offline questions
NSQC Approved 14

2.3 Steps for assessment development:

● Selection of assessment tool(s) is done as per the assessment criteria
prescribed in Qualification.
● For Associate- Regulatory Affairs and Intellectual Property (IVD and Medical
Devices assessment a blue print of the question paper, is part of assessment
tool for basic training.
● Development of lay-out of Question paper is such that the entire PCs
(Performance Criteria) of that qualification are covered.
● Score per question maps with the weightage given to that PC, in the
assessment criteria and the level of difficulty of the question.
● An expert from industry is selected who is called “Subject Matter Expert” (SME).
This SME must have over 13-15 years of experience in the industry in same
occupation.
● SME is screened and approved by LSSSDC. He is the oriented by both
LSSSDC and Assessment agency on – creating question Bank, level of
questions, end desired outcome of the assessment.
2.4 Execution of Basic Training Assessment:

● Post the assessment schedule confirmation of all trainees due for assessments
through Apprenticeship India portal, the assessment date for basic training is
decided with common agreement of Industry and LSSSDC and LSSSDC directs
it’s an assessment body/agency.
the assessment.
● The assessment is executed in two possible ways depending on the choice of
industry:
2.4.1 Tab based assessment using physical proctoring

2.4.2 Smart phone-based assessment using e-proctoring
2.4.1 Tab-based assessment using physical proctoring

● A representative from Assessment agency are present on the day of
assessment to execute the assessment at venue in case of physical proctoring.
NSQC Approved 15
● Assessment agency representative carries an identity card and letter from the
council authorising to conduct the assessment.
● Assessment agency representative ensures authenticity of Trainee’s identity by
verifying the documents (any document issued by GOI, such as Ration card,
Aadhaar Card, Driving Licence, Passport, election card etc)
● Assessment agency representative maintains the records of attendance, verified
documents and tablet instruments used in assessment.
● Assessment agency representative collects evidences of the assessment in best
possible way (videos, pictures, voice recordings etc)
● Assessment agency representative transfer the assessment scores from tab to
assessment agency server, using a secure, encrypted web-based program.
● The assessment agency after processing the results and putting them in
standard format hands over to LSSSDC within 7 days of assessment.
2.4.2 Smart phone-based assessment using e-proctoring

● All trainees due for assessments are registered on a assessment tool
application using their unique mobile number and e-mail ID along with a Govt.
ID issued proof.
● An assessment link is sent to the mail ID of each trainee with a defined expiry
date of the link.
● Trainee at any location can click on the link using his/her smart phone or a web
camera enabled computer system
● Using the unique credentials and govt ID number, trainee logs in for start of
assessment and completes the assessment.
● Authenticity of Trainee’s identity is done by assessment application by verifying
the documents (any document issued by GOI, such as Ration card, Aadhaar
Card, Driving Licence, Passport, election card etc.) and a live photo capture
● A live video of candidate during the assessment is captured to collect the
evidences of the assessment
● Once the assessment is complete, the assessment application automatically
assessment scores to assessment agency server, using a secure, encrypted
web-based program.
● The assessment agency after processing the results and putting them in
standard format hands over to LSSSDC within 7 days of assessment.
Assessment Result compilation:
● In case of offline OJT assessment -The OJT assessment results are sent to
LSSSDC by HR department of company in a sealed envelope for compiling the
assessment results.
● LSSSDC cross checks and validates the data and declares the result to Industry
and trainee.
● In case of online OJT assessment-Industry nominated assessor certified by
LSSSDC will be uploading the results on apprenticeshipindia.org portal.
● Passed trainees are provided with certificate.
NSQC Approved 16
Note: At any point of time assessment strategy would be as per the current
guidelines from MSDE.
● LSSSDC Protocol for Accreditation of Assessment Agencies and Assessment

Guideline Ver1.00 is attached as annexure 3
NSQC Approved 17
ASSESSMENT EVIDENCE
Marks Allocation
Skills
Assessment Assessment Criteria for Theor Proje
Practica Viva
outcomes outcomes y ct
l
1. LFS/N0570 Regulatory Dossier Preparation 15 30 10 5

v2.0: Development
PC1. collaborate with internal
of Technical
stakeholders - - - -
Dossier as per the
(manufacturing, R&D,
regulatory
stability) to compile
guidelines of
quality dossiers timely, as
intended market
per country specific
(India and Global)
requirements
for medical
devices and In- PC2. prepare a Technical
vitro Diagnostic Dossier that provides - - - -
Devices (IVD) detailed information on
your medical device/ in-
vitro diagnostic device
(IVD) ensuring
compliance with
regulatory and quality
framework as per country
specific regulatory
authority
PC3. ensure availability of
clinical data or clinical - - - -
studies / Trials data (as
applicable basis the
classification) in technical
dossier referring to the
subject device.
PC4. collaborate with research
team for Preparing a - - - -
Design Dossier, ensuring
compliance with
specific regulatory
authority, for CE Marking
application or other
NSQC Approved 18
Marks Allocation
Skills
Practica Viva
l
market authorization
applications
PC5. prepare a Clinical
Evaluation Report - - - -
(CER) and performance
evaluation report
according to regulatory
and quality framework as
per country specific
regulatory authority
PC6. prepare a Declaration of
Conformity (DoC), which - - - -
states that your device
complies with the
specific regulatory
authority
PC7. ensure implementation of
quality management - - - -
system (preferably ISO
13485), in collaboration
with design and quality
team in compliance with
the regulatory and quality
specific regulatory
authority
PC8. maintain a procedure for
design transfer as well as - - - -
maintain an approved
device master file with all
the approved design
specifications (i.e., design
outputs) for medical
device/ in-vitro diagnostic
NSQC Approved 19
Marks Allocation
Skills
Practica Viva
l
device (IVD) as per

PC9. facilitate in preparation of
certificate of analysis
(COA), technical data
sheet (TDS), method of
analysis (MOA), and any
other mandatory
document for product
registration as per
PC10. maintain locally the
database of product
registration
Regulatory Compliance for 10 15 10 5
labelling and inserts
PC11. outline requirements for
labelling, storage and - - - -
packaging as per
regulatory requirements
PC12. keeping a check on label
content and leaflets as - - - -
per regulatory norms
(Label proofing & Artwork)
PC13. create and edit Structured
Product Labels using - - - -
software like
pharmaready, Xforms or
any other.
PC14. perform label proofing
and artwork review with - - - -
the help of text verification
software like TVT or any
other.
PC15. review and facilitate
development of Patient - - - -
NSQC Approved 20
Marks Allocation
Skills
Practica Viva
l
information leaflet (PIL),

and package Insert for
regulatory dossier of an
intended application
Total 25 45 20 10
Operating the Regulatory 20 30 9 2

Systems
PC1. register the organization
on SUGAM portal of
Indian national regulator. - - - -
PC2. perform various
operations on SUGAM - - - -
portal related to
applications and related
Common Technical
Document (CTD), query
2. LFS/N0502 escalation and meeting
v3.0: Submission request with Indian
of Technical regulatory officers
Dossier as per the PC3. register the organization
regulatory on portal of regulator of - - - -
guidelines intended market/ country
PC4. perform various
operations on - - - -
international regulator
portal/ software (like
electronic submission
gateway (ESG), Common
European Submission Por
tal (CESP), eSubmission
gateway etc.) related to
applications, query
escalation and
supplement/ amendment
submissions as well as for
NSQC Approved 21
Marks Allocation
Skills
Practica Viva
l
tracking the application

status
PC5. ensure efficient
operations of international - - - -
regulator portal/ software
for Submission
Management, DLP, SLP
and Submission Dispatch,
Archival and
Troubleshooting during
the electronic Common
Technical Document
(eCTD) filing.
PC6. ensure eCTD Validation
Criteria, ICH Study
Tagging Files (ICH STF)
specifications and
Submission Transmission
Specifications ae met
while submitting the
eCTD.
PC7. ensure mitigation of risk in
eCTD publishing.
Regulatory Dossier Submission 10 20 3 6
PC8. prepare and submit

dossier for ASEAN - - - -
countries as per ACTD
format of respective
country
dossier for US, EU, - - - -
Canada, GCC, Australia,
Switzerland, South Africa,
Thailand as per eCTD
country
NSQC Approved 22
Marks Allocation
Skills
Practica Viva
l

dossier for Australia, New - - - -
Zealand, EU, Canada,
GCC, Bosnia and
Herzegovina as per NeeS
country
dossier for Emerging - - - -
market like LATAM,
MENA, APAC, ASEAN,
and CIS region as per
pCTD format of
respective country
dossier for European - - - -
region as per vNeeS
format
Total 30 50 12 8
3. LFS/N0569
v2.0: Assist in
managing the Regulatory facilitation for US 10 15 5 2
regulatory affairs Market
for medical PC1. facilitate for submission of
devices and In- investigational device - - - -
vitro Diagnostic exemption (IDE) for
Devices (IVD) regulatory approval.
PC2. facilitate for submission of
clinical trial applications - - - -
(CTA) for regulatory
approval.
Premarket notification - - - -
(PMN) application or
510(k) application for
Class 2 devices for
regulatory approval.
NSQC Approved 23
Marks Allocation
Skills
Practica Viva
l

Premarket approval - - - -
(PMA) application for
class 3 devices for
De Novo application for - - - -
novel medical devices
without a predicate for
Humanitarian Device - - - -
Exemption (HDE)
application for regulatory
approval
Regulatory facilitation for Indian 10 3
and Other Market 5 5
investigational device - - - -
(medical device/ IVD)
application / clinical study
approval for regulatory
approval for EU market.
Premarket approval - - - -
(PMA) application for
medical device/ IVD for
regulatory approval for
EU market
PC9. facilitate for regulatory
approval of medical - - - -
device/ IVD for market
authorization application
(MAA) via Gulf
Cooperation Council
procedure (GCC) for GCC
Countries
NSQC Approved 24
Marks Allocation
Skills
Practica Viva
l

the application for - - - -
manufacturing licence for
medical device/ In Vitro
Diagnostic Device (IVD)
from state or national
regulatory authority in
India as per applicable
classification
Regulatory facilitation for 5 10 5
Miscellaneous Approvals 2
PC11. classify the medical
device/ In Vitro Diagnostic - - - -
Device (IVD) as per
available classification
given by regulatory
authorities
PC12. register the medical
device/ In Vitro Diagnostic - - - -
Device (IVD) with
regulator and get Unique
Identification number
(UID) either country
specific or global as per
requirement
PC13. facilitate in obtaining
Institutional review board
(IRB) / ethics committee
approval for clinical trials
PC14. facilitate in obtaining
European CE Marking
Certificate for medical
device/ In Vitro Diagnostic
Device (IVD)
PC15. facilitate transition from
MDR to MDD for medical
device/ In Vitro Diagnostic
NSQC Approved 25
Marks Allocation
Skills
Practica Viva
l
Device (IVD) approved for

EU market
PC16. facilitate in getting the
manufacturing plant and
laboratory audited by a
notified body for
compliance with CE
marking and ISO 13485
QMS.
PC17. facilitate in obtaining test
license and certificate of
good manufacturing
practices from Indian drug
(CDSCO).
PC18. facilitate in obtaining the
free sale and commerce
certificate (FSC)/
certificate for export from
Indian Drug Regulatory
authority (CDSCO).
PC19. facilitate in liasoning and
filing submission with
national pharmaceutical
pricing authority (NPPA)
Regulatory facilitation for Post 5 10 5 3
Approval Changes
PC20. perform gap assessments
for post approval
compliance
PC21. facilitate the post approval
periodic reports
submission like Medical
device reporting (MDR)
and medical product
safety network (MedSun,
clinical evaluation reports
NSQC Approved 26
Marks Allocation
Skills
Practica Viva
l
(CER), post market

surveillance (PMS)
PC22. perform compliance
checks of current
registered information
versus manufacturing
documentation for
licensed medical device/
In Vitro Diagnostic Device
(IVD)
PC23. perform change control
review and management
while implementation of
vendor changes, lubricant
changes in machines, and
change in plant
machineries, design
specification updates or
any process changes etc.
PC24. prepare and facilitate
submission of variations
to the regulators to close
the identified ‘compliance
gaps’
PC25. provide strategic support
to internal management /
clients (in case providing
services) in advising on
the appropriate processes
and procedures to ensure
sustainable compliance
Total 25 45 20 10
4. LFS/N0571 IPR Management 30 50 10 10
v2.0: Assist in PC1. develop initial
intellectual understanding of the - - - -
property rights invention, creating search
NSQC Approved 27
Marks Allocation
Skills
Practica Viva
l
management for strategies, executing

life sciences search strategies.
products and PC2. collect the relevant
assets information on products, - - - -
probable customers and
competitors from API
Marketing team, IP or
secondary sources (IMS,
Scifinder, Newport, IPD
Analytics).
PC3. conduct comprehensive
patent searches of - - - -
technical and patent
information using online
database and other
information resources.
PC4. perform prior Art Search /
Patentability Search by - - - -
using various paid and
freely available databases
PC5. perform extracting and
evaluating search results, - - - -
culling, report formation,
mapping and result
evaluation, rejection
summary and
visualization through
charts
PC6. create, update & maintain
the required reports with - - - -
the correct information &
naming convention.
PC7. perform patent
infringement analysis for - - - -
various jurisdiction.
PC8. assist in preliminary
evaluation based on sales - - - -
NSQC Approved 28
Marks Allocation
Skills
Practica Viva
l
projection, possible
competitors, expert
comments for the success
of molecule, IP Analysis
etc.
PC9. assist in preparation of
patent landscape report - - - -
for API/ Formulation/
Biological products/
Medical Devices/ In-vitro
diagnostic devices (IVD)
as per organizational
need.
PC10. assist in drafting In-house
opinion reports for the - - - -
Invalidation of patents.
PC11. facilitate in providing
clearance reports for - - - -
various markets.
PC12. draft patent application for
provisional/ non - - - -
provisional & complete
filing.
PC13. assist in prosecution of
patent application in
collaboration with legal
department for national
and global markets
PC14. liaise with multiple
organizational functions
like legal, regulatory
affairs, research&
development, medical
affairs, marketing team to
gather and validate cross-
functional inputs required
for decision making
NSQC Approved 29
Marks Allocation
Skills
Practica Viva
l
Total 30 50 10 10
5. LFS/N0567 Coordination with Manager 5 10 3 2
v2.0: Coordinate PC1. effectively communicate
with Manager, and collaborate with - - - -
R&D team, other manager in order to
cross-functional develop regulatory
teams, external strategies
stakeholders and PC2. provide local regulation
regulatory intelligence to manager for - - - -
agencies to efficient regulatory affairs
manage regulatory management
affairs operations
PC3. maintain protocol-related
documents and get them - - - -
reviewed and approved by
manager
PC4. identify problems arising - - - -
within the process,
resulting from change
management or due to
change in vendors, or
human error, and escalate
the same by following the
proper escalation matrix
Coordination with R&D Team 5 10 3 2
PC5. coordinate with various
technical professionals to - - - -
gather, organize and
compile information on
new products or
processes and maintain
confidentiality
PC6. work effectively with other - - - -
staff in clinical operations
(e.g., biostatistics, data
management, clinical
NSQC Approved 30
Marks Allocation
Skills
Practica Viva
l
monitoring), regulatory
affairs and others in team.
PC7. maintain protocol-related - - - -
documents by obtaining
approval from required
departments and review
staff
Coordination with cross-
functional teams 5 10 3 2
PC8. coordinate with the quality - - - -

and production team for
required facilitation in
various activities for
regulatory compliance
PC9. coordinate with BA/BE and - - - -
Clinical Trail Team for
seeking the status of
project and for filing the
IND supplements and
other reports
PC10. coordinate with
pharmacovigilance team - - - -
for periodic product safety
reporting
PC11. coordinate with the
product development team - - - -
for development of CMC
related documents
PC12. support the Regulatory
prices related decision - - - -
making in collaboration
with commercial
department
NSQC Approved 31
Marks Allocation
Skills
Practica Viva
l
Coordination with External 5 10 5 5

Stakeholders and Regulatory
Agencies
PC13. collaborate with the local
Regulatory liaison agent - - - -
for smooth execution &
liasoning
PC14. participate in Ethics
Committee Meetings as - - - -
and when required
PC15. maintain cordial
relationship with the - - - -
national and state level
regulatory authorities for
keeping self and
organization updated and
abreast with latest
changes in regulations as
well as status of
applications
PC16. obtaining market
permissions and approvals - - - -
for company distributers
as per regulatory laws if
any
Sensitivity towards all genders
and people with disability 5 5 3 2
PC17. respect all genders, - - - -
religions, and caste
PC18. empathize with people - - - -
with disability
PC19. offer support or help to a
person with disability only - - - -
when asked
PC20. ensure to adhere with the
guidelines laid in Sexual - - - -
NSQC Approved 32
Marks Allocation
Skills
Practica Viva
l
Harassment of Women at
Workplace (Prevention,
Prohibition and Redressal)
Act
PC21. report any violation of
prevention of sexual - - - -
harassment (POSH) rules
immediately to the POSH
committee
Total 25 45 17 13
6. LFS/N0122 Adhere to health and hygiene
10 10 3 2
v2.0: Ensure protocols
adherence to PC1. comply with health and
Environment, personal hygiene-related
health and safety protocols as per WHO - - - -
guidelines at standards and ICH GMP
workplace by self guidelines
and subordinates PC2. sanitize your hands and
follow cleanroom protocol,
if applicable before
entering in laboratory and - - - -
production area and
ensure the adherence of
same by subordinates
PC3. report any allergy,
sickness or any other
environment-related
breach before or after - - - -
entering the work
premises to the
designated person
PC4. take preventive actions on
the report of any allergy,
sickness or any other
- - - -
environment-related
breach reported by
subordinates
NSQC Approved 33
Marks Allocation
Skills
Practica Viva
l
Adhere to safety and security

10 10 2 2
procedures
PC5. observe compliance by
self and subordinates with
- - - -
safety and security
policies and procedures
PC6. ensure the use of
appropriate safety gears
like headgear, masks,
gloves and other
accessories as mentioned
- - - -
in the guidelines, by self
and subordinates while
working or visiting the
manufacturing or
laboratory area
PC7. take preventive and
corrective actions on the
report of any identified
breaches in safety and
- - - -
security policies and
procedures by
subordinates and team
mates
PC8. ensure proper material
segregation and labelling - - - -
at workplace
PC9. comply with material
handling, segregation and
- - - -
storage as per 5S system
at workplace
Adhere to emergency procedures 10 10 3 3
PC10. report any hazards that
he/she is not competent
- - - -
to deal with the relevant
EHS personnel and warn
NSQC Approved 34
Marks Allocation
Skills
Practica Viva
l
other people who may be

affected
PC11. raise the alarm and inform
the concerned person
immediately for action in
- - - -
the cases of spill, fall,
injury, toxic inhale, fire or
explosion
PC12. follow emergency
protocols for any alarms
and ensure the safety of - - - -
subordinates in the area
under supervision
PC13. follow emergency
- - - -
procedures efficiently
PC14. ensure injured employees
are provided appropriate - - - -
first aid and medical aid
Environment Sustainability 10 10 2 3
PC15. ensure energy
conservation by switching
off the machine (including
- - - -
laptops etc.) and
equipment post
operations
PC16. identify ways to optimize
the usage of
electricity/energy in - - - -
various
tasks/activities/processes
PC17. ensure energy
conservation by
optimizing the machine - - - -
(including laptop etc) /
equipment performance
NSQC Approved 35
Marks Allocation
Skills
Practica Viva
l
PC18. identify recyclable and

non-recyclable, and
- - - -
hazardous waste
generated
PC19. segregate waste into
different categories to
achieve minimum - - - -
pollution of land and
water
PC20. Ensure no water leakage
in work area and take - - - -
corrective actions, if any
Total 40 40 10 10
7. Introduction to Employability 1 1 - -
DGT/VSQ/N0103 Skills
V1.0: PC 1. understand the - - - -
Employability significance of
Skills (90 Hours) employability skills in
meeting the current job
market requirement and
future of work.
PC 2. identify and explore - - - -
learning and employability
relevant portals
PC 3. research about the
different industries, job
market trends, latest skills
required and the available
opportunities
Constitutional values – 1 1 - -
Citizenship
PC 4. recognize the significance - - - -
of constitutional values,
including civic rights and
duties, citizenship,
responsibility towards
NSQC Approved 36
Marks Allocation
Skills
Practica Viva
l
society etc. and personal

values and ethics such as
honesty, integrity, caring
and respecting others, etc.
PC 5. follow environmentally - - - -
sustainable practices
Becoming a Professional in the 1 3 - -
21st Century
PC 6. recognize the significance - - - -
of 21st Century Skills for
employment
PC 7. practice the 21st Century - - - -
Skills such as Self-
Awareness, Behavior
Skills, time management,
critical and adaptive
thinking, problem-solving,
creative thinking, social
and cultural awareness,
emotional awareness,
learning to learn for
continuous learning etc. in
personal and professional
life
PC 8. adopt a continuous
learning mindset for
personal and professional
development
Basic English Skills 3 4 - -
PC 9. use basic English for - - - -
everyday conversation in
different contexts, in
person and over the
telephone
PC 10. read and understand - - - -
routine information, notes,
NSQC Approved 37
Marks Allocation
Skills
Practica Viva
l
instructions, mails, letters

etc. written in English
PC 11. write short messages, - - - -
notes, letters, e-mails etc.
in English
Career Development & 1 2 - -
Goal Setting
PC 12. identify career goals - - - -
based on the skills,
interests, knowledge, and
personal attributes
PC 13. prepare a career - - - -
development plan with
short- and long-term
goals.
Communication Skills 2 2 - -
PC 14. follow verbal and non- - - - -
verbal communication
etiquette while
communicating in
professional and public
settings
PC 15. use active listening - - - -
techniques for effective
communication
PC 16. communicate in writing
using appropriate style
and format based on
formal or informal
requirements
PC 17. work collaboratively with
others in a team
Diversity & Inclusion 1 1 - -
PC 18. communicate and behave - - - -
appropriately with all
genders and PwD
NSQC Approved 38
Marks Allocation
Skills
Practica Viva
l
PC 19. escalate any issues - - - -

related to sexual
harassment at workplace
according to POSH Act
Financial and Legal 2 3 - -
Literacy
PC 20. identify and select reliable - - - -
institutions for various
financial products and
services such as bank
account, debit and credit
cards, loans, insurance
etc.
PC 21. carry out offline and online - - - -
financial transactions,
safely and securely, using
various methods and
check the entries in the
passbook
PC 22. identify common - - - -
components of salary and
compute income,
expenses, taxes,
investments etc
PC 23. identify relevant rights and - - - -
laws and use legal aids to
fight against legal
exploitation
Essential Digital Skills 3 5 - -
PC 24. operate digital devices and - - - -
carry out basic internet
operations securely and
safely
PC 25. carry out basic internet - - - -
operations by connecting
to the internet safely and
NSQC Approved 39
Marks Allocation
Skills
Practica Viva
l
securely, using the mobile

data or other available
networks through
Bluetooth, Wi-Fi, etc.
PC 26. display responsible online - - - -
behavior while using
various social media
platforms
PC 27. create a personal email
account, send and
process received
messages as per
requirement
PC 28. carry out basic procedures
in documents,
spreadsheets and
presentations using
respective and appropriate
applications
PC 29. utilize virtual collaboration
tools to work effectively
Entrepreneurship 2 3 - -
PC 30. identify different types of - - - -
Entrepreneurship and
Enterprises and assess
opportunities for potential
business through research
PC 31. develop a business plan - - - -
and a work model,
considering the 4Ps of
Marketing Product, Price,
Place and Promotion
PC 32. identify sources of funding, - - - -
anticipate, and mitigate
any financial/ legal hurdles
NSQC Approved 40
Marks Allocation
Skills
Practica Viva
l
for the potential business

opportunity
Customer Service 1 2 - -
PC 33. identify different types of - - - -
customers and ways to
communicate with them
PC 34. identify and respond to - - - -
customer requests and
needs in a professional
manner
PC 35. use appropriate tools to - - - -
collect customer feedback
PC 36. follow appropriate hygiene
and grooming standards
Getting ready for 2 3 - -
apprenticeship & Jobs
PC 37. create a professional - - - -
Curriculum vitae (Résumé)
PC 38. search for suitable jobs - - - -
using reliable offline and
online sources such as
Employment exchange,
recruitment agencies,
newspapers etc. and job
portals, respectively
PC 39. apply to identified job - - - -
openings using offline
/online methods as per
requirement
PC 40. answer questions politely, - - - -
with clarity and
confidence, during
recruitment and selection
PC 41. identify apprenticeship - - - -
opportunities and register
NSQC Approved 41
Marks Allocation
Skills
Practica Viva
l
for it as per guidelines and

requirements
NOS Total 20 30 - -
8.LFS/N0120 v2.0: Set up enterprise and perform 10 15 5 5
Establish own entrepreneurial activities
enterprise and PC1. perform a survey in the
perform various identified area for - - - -
entrepreneurial business activities to
activities to run the identify prospective
business customers and business
operations in Life opportunity
Sciences Sector PC2. identify products and/ or
services and it's sources, - - - -
that match the business
opportunity
PC3. develop business proposal
with objective and - - - -
identified business area
for registering the
proposed business as
independent entity with
competent authorities
PC4. submit business proposals
and feasibility plans for - - - -
securing the required
funding from govt.
schemes for MSMEs like
MUDRA etc. as and when
needed
PC5. present the business
proposal to investors and - - - -
stakeholders to gain their
confidence and trust for
possible funding
PC6. ensure setting up the
infrastructure and - - - -
NSQC Approved 42
Marks Allocation
Skills
Practica Viva
l
resources for business as

per approved plan and
investors/ shareholders
agreement
PC7. enrol into various
government schemes and - - - -
programs for MSME and
avail the benefits
PC8. promote the product/
services through various - - - -
means including digital
promotions in line to
regulations for promotion
and sale as per land of law
PC9. develop the supply chain
and distribution network - - - -
PC10. maintain updated
information regarding new
market trends to provide
service to customers and
constantly upskill self and
employees for futuristic
technologies, innovations
and methodologies
Maintenance of accounts and 10 15 5 5
ledgers
PC11. ensure to generate a final
invoice for the services - - - -
rendered/ or products sold
PC12. collect payment either in
cash (as per RBI - - - -
guidelines)/ cheque/
demand draft or through
online transactions via
RTGS/NEFT/UPI etc.
NSQC Approved 43
Marks Allocation
Skills
Practica Viva
l
PC13. ensure accounts and

ledgers are maintained for - - - -
the material supplied,
payables and receivables,
loan ledgers, taxes
collected and paid into
government treasury as
well for wages paid and
statutory benefits like PF,
ESI contribution deposited
with authorities
PC14. ensure maintenance and
reconciliation of a monthly - - - -
account as well as
movable and immovable
assets and stock to keep
track of profit/ loss as well
as periodic audit as per
legal requirements
Comply with legal, regulatory and 10 10 5 5
statutory standards
PC15. comply with workplace
health and safety rules - - - -
stipulated by local
authorities
PC16. comply with rules related
to taxes and licensing - - - -
regulations
PC17. comply with prevalent
labour laws and keep - - - -
records for employee’s
qualifications, employment
as well as trainings
PC18. comply with regulations
and protocols related to - - - -
maintenance of product/
NSQC Approved 44
Marks Allocation
Skills
Practica Viva
l
service license including

the pre conditions (if any)
PC19. comply with quality system
like ISO/GMP/GLP etc and - - - -
any other rule mandated
by appropriate regulatory
authorities
PC20. comply with pollution
norms as per land of law - - - -
and ensure near zero
pollution for a sustainable
environment and to earn
carbon credits
PC21. ensure that business
facility and employees are - - - -
always prepared and
ready for any surprise
inspection/ audit from
clients/ regulatory/
statutory authorities
30 40 15 15
Total
9. LFS/N0121 Infrastructure related 5 20 5 2

v2.0: Maintain the documentation
critical business PC1. ensure documentation and
documents as maintenance of records for - - - -
Entrepreneur in architectural building
Life Sciences layout like blueprint of
Sector plant/lab, electric circuit
and plumbing layouts and
safety equipment layout,
infrastructure and asset
insurance and lease/rent
contracts/ sale deed (if
owned facility)
PC2. ensure documentation and
maintenance of records for - - - -
NSQC Approved 45
Marks Allocation
Skills
Practica Viva
l
all machineries, equipment

and tools installed/used in
the plant/ lab unit, with
supplier/manufacturer
details, manuals of all
machineries / equipment,
installation and
qualification records and
annual maintenance
details etc
engineering and
maintenance of each
machinery/equipment,
machine utilization,
machine performance,
breakdown details,
corrective actions, spares
changed,
machine/equipment
condition etc
Supply Chain related 5 20 5 3
documentation
all raw materials,
ingredients and packaging
materials handled, like
name of the supplier,
batch details, quantity
supplied and quality of the
materials supplies etc as
well as
each supplier quality
NSQC Approved 46
Marks Allocation
Skills
Practica Viva
l
report on raw materials,

ingredients, packaging
materials, internal and
external quality report on
finished products,
consumer and customer
complaints , corrective
actions, legal documents
(if any)
storage facility, like
condition of storage
facility, storage
parameters if any like
temperature, humidity,
pressure (as applicable),
space utilised, stacking
procedure etc
distribution details like
transport details, quality,
hygiene and cleanliness of
vehicle, quantity loaded in
the vehicle, distribution
routes , outlet details,
customer/ consumer
details, distribution
quantity, quantity returned
etc.
Documentation for sales & 5 10 3 3
marketing
long term and short term
business plans, feasibility
NSQC Approved 47
Marks Allocation
Skills
Practica Viva
l
reports,
investor/shareholder
agreements and
disbursement and
payment records for
loan/grant/equity etc.
sale like customer details,
customer type, location,
quantity purchased by
each stockist/consumer,
frequency of purchase,
sale details like quantity of
products/brand sold in
each territory
Quality audit and client/regulatory 5 5 2 2
inspections related
documentation
internal/ external audits
with its observations,
notices/ feedback, action
reports and final
submission of audit action
reports
every communication sent
to or received from
regulatory/ licensing
authorities
NOS Total 20 55 15 10
NSQC Approved 48
24. Assessment evidences
Title of Component: 1. LFS/N0570 v2.0: Development of Technical Dossier as per

the regulatory guidelines of intended market (India and Global) for medical devices
and In-vitro Diagnostic Devices (IVD)
Outcomes to be Assessment criteria for the outcome

assessed/NOSs to be
assessed
Regulatory Dossier PC1. collaborate with internal stakeholders
Preparation (manufacturing, R&D, stability) to compile quality
dossiers timely, as per country specific requirements
PC2. prepare a Technical Dossier that provides detailed
information on your medical device/ in-vitro diagnostic
device (IVD) ensuring compliance with regulatory and
quality framework as per country specific regulatory
authority
PC3. ensure availability of clinical data or clinical studies
/ Trials data (as applicable basis the classification) in
technical dossier referring to the subject device.
PC4. collaborate with research team for Prepare a
Design Dossier, ensuring compliance with regulatory and
authority, for CE Marking application or other market
authorization applications
PC5. prepare a Clinical Evaluation Report (CER) and
performance evaluation report according to regulatory
and quality framework as per country specific regulatory
authority
PC6. prepare a Declaration of Conformity (DoC), which
states that your device complies with the regulatory and
authority
PC7. ensure implementation of quality management
system (preferably ISO 13485), in collaboration with
design and quality team in compliance with the
regulatory and quality framework as per country specific
PC8. maintain a procedure for design transfer as well as
maintain an approved device master file with all the
approved design specifications (i.e., design outputs) for
NSQC Approved 49
medical device/ in-vitro diagnostic device (IVD) as per
PC9. facilitate in preparation of certificate of analysis
(COA), technical data sheet (TDS), method of analysis
(MOA), and any other mandatory document for product
registration as per regulatory guidelines
PC10. maintain locally the database of product
registration
Regulatory Compliance for PC11. outline requirements for labelling, storage and
labelling and inserts packaging as per regulatory requirements
PC12. keeping a check on label content and leaflets as
per regulatory norms (Label proofing & Artwork)
PC13. create and edit Structured Product Labels using
software like pharmaready, Xforms or any other.
PC14. perform label proofing and artwork review with the
help of text verification software like TVT or any other.
PC15. review and facilitate development of Patient
information leaflet (PIL), and package Insert for
regulatory dossier of an intended application
Means of assessment 1 Digital Written test for knowledge assessment:
Scope – Is used to test the knowledge component of the
Qualification.
Method – objective type questions, match the columns,
fill in the blanks, tick the odd man out, choose the correct
option, choose the best answer, True or false, Identify
the object, tool or machinery, arrange in proper
sequence, case study, scenario-based responses.
Analysis – Question paper is divided in sections. Each
Section intends to assess a particular knowledge field of
the trainee. Thus, section wise calculation of marks gives
the clear idea of the areas of improvement or expertise
of the trainee. While a consolidated mark gives the
overall rating of the trainee.
Means of assessment 2 Digital Written test for skill assessment
Scope – Is used to test primarily the Skill component of
the qualification. Trainee’s expertise in handling and
managing the situation is tested.
Tools – computer or tab based online or offline
questions.
Method – A situation is narrated or created in the
question posed to the trainee and he is asked objective
NSQC Approved 50
type questions to select the correct reaction to the
situation. The selected situations are based on real
situations.
Section intends to assess a particular skill field of the
trainee. Thus, section wise calculation of marks gives the
clear idea of the areas of improvement or expertise of
the trainee. While a consolidated mark gives the overall
rating of the trainee.
Means of assessment 3 Project Assessment
the qualification. Trainee’s expertise in utilization of
knowledge and skills in real life job scenarios
Tools – Project report.
Method – The trainee is deployed in Industry for on the
job trainee or is being asked to work on a specific project
(utilizing skills as per qualification). A project report duly
endorsed by his/her project supervisor is prepared by the
trainee and submitted for evaluation. The Assessor asks
Direct questions open and close ended questions,
situation-based questions, analytical questions, and
decision-making based questions based on the project
report
Analysis –Project Assessments are analysed on
knowledge and skill component.
Means of assessment 4 Viva
Scope – Is used to test the knowledge and
understanding and breadth of awareness about the
subject.
Some personality traits and generic skills (such as –
promptness, sharpness, communication skills, depth of
knowledge, comprehension, presentation, patience etc)
Method – Direct questions open and close ended
questions, situation-based questions, analytical
questions, and decision-making based questions.
Different questions are included to test relevant PCs
from the qualification
Analysis – Assessor is provided with spectrum of ready
answers to be expected from trainee. This reduces effect
of subjectivity of the assessor. Comparative quality of
NSQC Approved 51
trainees with in a batch or different institutes can be
gauged
Pass/Fail
The aggregate pass marks for Digital Written test for knowledge assessment, Digital
Written test for skill assessment, Project and Viva is 70%. In case of RPL where Project
will not be there ,the aggregate pass marks for Digital Written test for knowledge
assessment, Digital Written test for skill assessment and Viva shall also be 70%.
Title of Component: 2. LFS/N0502 v3.0: Submission of Technical Dossier as per

the regulatory guidelines

assessed/NOSs to be
assessed
Operating the Regulatory PC1. register the organization on SUGAM portal of
Systems Indian national regulator.
PC2. perform various operations on SUGAM portal
related to applications and related Common Technical
Document (CTD), query escalation and meeting
request with Indian regulatory officers
PC3. register the organization on portal of regulator of
intended market/ country
PC4. perform various operations on international
regulator portal/ software (like electronic submission
gateway (ESG), Common
European Submission Portal (CESP), eSubmission
gateway etc.) related to applications, query escalation
and supplement/ amendment submissions as well as
for tracking the application status
PC5. ensure efficient operations of international
regulator portal/ software for Submission
Management, DLP, SLP and Submission Dispatch,
Archival and Troubleshooting during the electronic
Common Technical Document (eCTD) filing.
PC6. ensure eCTD Validation Criteria, ICH Study
Tagging Files (ICH STF) specifications and
Submission Transmission Specifications ae met while
submitting the eCTD.
PC7. ensure mitigation of risk in eCTD publishing.
NSQC Approved 52
PC8.prepare and submit dossier for ASEAN countries
Regulatory Dossier as per ACTD format of respective country
Submission PC9. prepare and submit dossier for US, EU, Canada,
GCC, Australia, Switzerland, South Africa, Thailand as - -
per eCTD format of respective country
PC10. prepare and submit dossier for Australia, New
Zealand, EU, Canada, GCC, Bosnia and Herzegovina
as per NeeS format of respective country
PC11. prepare and submit dossier for Emerging
market like LATAM, MENA, APAC, ASEAN, and CIS
region as per pCTD format of respective country
PC12. prepare and submit dossier for European
region as per vNeeS format
Scope – Is used to test the knowledge component of
the Qualification.
Method – objective type questions, match the
columns, fill in the blanks, tick the odd man out,
choose the correct option, choose the best answer,
True or false, Identify the object, tool or machinery,
arrange in proper sequence, case study, scenario-
based responses.
Section intends to assess a particular knowledge field
of the trainee. Thus, section wise calculation of marks
gives the clear idea of the areas of improvement or
expertise of the trainee. While a consolidated mark
gives the overall rating of the trainee.
Scope – Is used to test primarily the Skill component
of the qualification. Trainee’s expertise in handling and
questions.
question posed to the trainee and he is asked
objective type questions to select the correct reaction
to the situation. The selected situations are based on
real situations.
NSQC Approved 53
trainee. Thus, section wise calculation of marks gives
of the qualification. Trainee’s expertise in utilization of
job trainee or is being asked to work on a specific
project (utilizing skills as per qualification). A project
report duly endorsed by his/her project supervisor is
prepared by the trainee and submitted for evaluation.
The Assessor asks Direct questions open and close
ended questions, situation-based questions, analytical
questions, and decision-making based questions
based on the project report
subject.
promptness, sharpness, communication skills, depth
of knowledge, comprehension, presentation, patience
etc) can also be tested required for the qualification.
Tools – Direct dialogue between assessor and
Trainee.
Analysis – Assessor is provided with spectrum of
ready answers to be expected from trainee. This
reduces effect of subjectivity of the assessor.
Comparative quality of trainees with in a batch or
different institutes can be gauged
Pass/Fail
Written test for skill assessment, Project and Viva is 70%. In case of RPL where
NSQC Approved 54
Project will not be there ,the aggregate pass marks for Digital Written test for
knowledge assessment, Digital Written test for skill assessment and Viva shall also
be 70%.
Title of Component: 3. LFS/N0569 v2.0: Assist in managing the regulatory affairs

for medical devices and In-vitro Diagnostic Devices (IVD)

assessed/NOSs to be
assessed
Regulatory facilitation for US PC1. facilitate for submission of investigational device
Market exemption (IDE) for regulatory approval.
PC2. facilitate for submission of clinical trial applications
(CTA) for regulatory approval.
PC3. facilitate for submission of Premarket notification
(PMN) application or 510(k) application for Class 2
devices for regulatory approval.
PC4. facilitate for submission of Premarket approval
(PMA) application for class 3 devices for regulatory
approval.
PC5. facilitate for submission of De Novo application for
novel medical devices without a predicate for regulatory
approval.
PC6. facilitate for submission of Humanitarian Device
Exemption (HDE) application for regulatory approval
Regulatory facilitation for PC7. facilitate for submission of investigational device
Indian and Other Market (medical device/ IVD) application / clinical study approval
for regulatory approval for EU market.
PC8. facilitate for submission of Premarket approval
(PMA) application for medical device/ IVD for regulatory
approval for EU market
PC9. facilitate for regulatory approval of medical device/
IVD for market authorization application (MAA) via Gulf
Cooperation Council procedure (GCC) for GCC
Countries
PC10. facilitate for submission of the application for
manufacturing licence for medical device/ In Vitro
Diagnostic Device (IVD) from state or national regulatory
authority in India as per applicable classification
NSQC Approved 55
Regulatory facilitation for PC11. classify the medical device/ In Vitro Diagnostic
Miscellaneous Approvals Device (IVD) as per available classification given by
regulatory authorities
PC12. register the medical device/ In Vitro Diagnostic
Device (IVD) with regulator and get Unique Identification
number (UID) either country specific or global as per
requirement
PC13. facilitate in obtaining Institutional review board
(IRB) / ethics committee approval for clinical trials
PC14. facilitate in obtaining European CE Marking
Certificate for medical device/ In Vitro Diagnostic Device
(IVD)
PC15. facilitate transition from MDR to MDD for medical
device/ In Vitro Diagnostic Device (IVD) approved for EU
market
PC16. facilitate in getting the manufacturing plant and
laboratory audited by a notified body for compliance with
CE marking and ISO 13485 QMS.
PC17. facilitate in obtaining test license and certificate of
good manufacturing practices from Indian drug
regulatory authority (CDSCO).
PC18. facilitate in obtaining the free sale and commerce
certificate (FSC)/ certificate for export from Indian Drug
Regulatory authority (CDSCO).
PC19. facilitate in liasoning and filing submission with
national pharmaceutical pricing authority (NPPA)
Regulatory facilitation for Post PC20. perform gap assessments for post approval
Approval Changes compliance
PC21. facilitate the post approval periodic reports
submission like Medical device reporting (MDR) and
medical product safety network (MedSun, clinical
evaluation reports (CER), post market surveillance
(PMS)
PC22. perform compliance checks of current registered
information versus manufacturing documentation for
licensed medical device/ In Vitro Diagnostic Device (IVD)
PC23. perform change control review and management
while implementation of vendor changes, lubricant
changes in machines, and change in plant machineries,
design specification updates or any process changes
etc.
NSQC Approved 56
PC24. prepare and facilitate submission of variations to
the regulators to close the identified ‘compliance gaps’
PC25. provide strategic support to internal
management/clients (in case providing services) in
advising on the appropriate processes and procedures to
ensure sustainable compliance
Qualification.
questions.
situations.
NSQC Approved 57
report
subject.
gauged
Pass/Fail
NSQC Approved 58
Title of Component: 4. LFS/N0571 v2.0: Assist in intellectual property rights
management for life sciences products and assets
assessed/NOSs to be
assessed
IPR Management PC1. develop initial understanding of the invention,
creating search strategies, executing search
strategies.
PC2. collect the relevant information on products,
probable customers and competitors from API
Marketing team, IP or secondary sources (IMS,
Scifinder, Newport, IPD Analytics).
PC3. conduct comprehensive patent searches of
technical and patent information using online database
and other information resources.
PC4. perform prior Art Search / Patentability Search
by using various paid and freely available databases
PC5. perform extracting and evaluating search results,
culling, report formation, mapping and result
evaluation, rejection summary and visualization
through charts
PC6. create, update & maintain the required reports
with the correct information & naming convention.
PC7. perform patent infringement analysis for various
jurisdiction.
PC8. assist in preliminary evaluation based on sales
projection, possible competitors, expert comments for
the success of molecule, IP Analysis etc.
PC9. assist in preparation of patent landscape report
for API/ Formulation/ Biological products/ Medical
Devices/ In-vitro diagnostic devices (IVD) as per
organizational need.
PC10. assist in drafting In-house opinion reports for
the Invalidation of patents.
PC11. facilitate in providing clearance reports for
various markets.
PC12. draft patent application for provisional/ non
provisional & complete filing.
PC13. assist in prosecution of patent application in
collaboration with legal department for national and
global markets
NSQC Approved 59
PC14. liaise with multiple organizational functions like
legal, regulatory affairs, research& development,
medical affairs, marketing team to gather and validate
cross-functional inputs required for decision making
the Qualification.
based responses.
questions.
real situations.
NSQC Approved 60
subject.
Trainee.
Pass/Fail
be 70%.
NSQC Approved 61
Title of Component: 5. LFS/N0567 v2.0: Coordinate with Manager, R&D team,
other cross-functional teams, external stakeholders and regulatory agencies to
manage regulatory affairs operations

assessed/NOSs to be
assessed
Coordination with Manager PC1.effectively communicate and collaborate with
manager in order to develop regulatory strategies
PC2. provide local regulation intelligence to manager
for efficient regulatory affairs management
PC3. maintain protocol-related documents and get
them reviewed and approved by manager
PC4. identify problems arising within the process,
resulting from change management or due to change in
vendors, or human error, and escalate the same by
following the proper escalation matrix
Coordination with R&D team PC5. coordinate with various technical professionals to
gather, organize and compile information on new
products or processes and maintain confidentiality
PC6. work effectively with other staff in clinical
operations (e.g., biostatistics, data management,
clinical monitoring), regulatory affairs and others in
team.
PC7. maintain protocol-related documents by obtaining
approval from required departments and review staff
Coordination with team and PC8. coordinate with the quality and production team
cross-functional for required facilitation in various activities for regulatory
compliance
PC9. Coordinate with BA/BE and Clinical Trail Team for
seeking the status of project and for filing the IND
supplements and other reports
PC10. Coordinate with pharmacovigilance team for
periodic product safety reporting
PC11. coordinate with the product development team
for development of CMC related documents
PC12. Support the Regulatory prices related decision
making in collaboration with commercial department
PC13. collaborate with the local Regulatory liaison
agent for smooth execution & liasoning
NSQC Approved 62
Coordination with External PC14. Participate in Ethics Committee Meetings as and
Stakeholders and Regulatory when required
Agencies PC15. Maintain cordial relationship with the national
and state level regulatory authorities for keeping self
and organization updated and abreast with latest
changes in regulations as well as status of applications
PC16. Obtaining market permissions and approvals for
company distributers as per regulatory laws if any
PC17. collaborate with the local Regulatory liaison
agent for smooth execution & liasoning
Sensitivity towards all genders PC18. respect all genders, religions, and caste
and people with disability PC19. empathize with people with disability
PC20. offer support or help to a person with disability
only when asked
PC21. ensure to adhere with the guidelines laid in
Sexual Harassment of Women at Workplace
(Prevention, Prohibition and Redressal) Act
PC22. report any violation of prevention of sexual
harassment (POSH) rules immediately to the POSH
committee
the Qualification.
based responses.
NSQC Approved 63
questions.
real situations.
subject.
Trainee.
NSQC Approved 64
Pass/Fail
Project will not be there, the aggregate pass marks for Digital Written test for
be 70%.
NSQC Approved 65
Title of Component: 6. LFS/N0122 v2.0: Ensure adherence to Environment, health
and safety guidelines at workplace by self and subordinates

assessed/NOSs to be
assessed
Adhere to health and hygiene PC1. comply with health and personal hygiene-related
protocols protocols as per WHO standards and ICH GMP
guidelines
PC2. sanitize your hands and follow cleanroom
protocol, if applicable before entering in laboratory and
production area and ensure the adherence of same by
subordinates
PC3. report any allergy, sickness or any other
environment-related breach before or after entering
the work premises to the designated person
PC4. take preventive actions on the report of any
allergy, sickness or any other environment-related
breach reported by subordinates
Adhere to safety and security PC5. observe compliance by self and subordinates
procedures with safety and security policies and procedures
PC6. ensure the use of appropriate safety gears like
headgear, masks, gloves and other accessories as
mentioned in the guidelines, by self and subordinates
while working or visiting the manufacturing or
laboratory area
PC7. take preventive and corrective actions on the
report of any identified breaches in safety and security
policies and procedures by subordinates and team
mates
PC8. ensure proper material segregation and labelling
at workplace
PC9. comply with material handling, segregation and
storage as per 5S system at workplace
PC10. report any hazards that he/she is not competent
Adhere to emergency to deal with the relevant EHS personnel and warn
procedures other people who may be affected
PC11. raise the alarm and inform the concerned
person immediately for action in the cases of spill, fall,
injury, toxic inhale, fire or explosion
NSQC Approved 66
PC12. follow emergency protocols for any alarms and
ensure the safety of subordinates in the area under
supervision
PC13. follow emergency procedures efficiently
PC14. ensure injured employees are provided
appropriate first aid and medical aid
Environment Sustainability PC15. ensure energy conservation by switching off the
machine (including laptops etc.) and equipment post
operations
PC16. identify ways to optimize the usage of
electricity/energy in various tasks/activities/processes
PC17. ensure energy conservation by optimizing the
machine (including laptop etc) / equipment
performance
PC18. identify recyclable and non-recyclable, and
hazardous waste generated
PC19. segregate waste into different categories to
achieve minimum pollution of land and water
PC20. ensure no water leakage in work area and take
corrective actions, if any
the Qualification.
based responses.
NSQC Approved 67
questions.
real situations.
subject.
Trainee.
NSQC Approved 68
Pass/Fail
be 70%.
NSQC Approved 69
Title of Component: 7. DGT/VSQ/N0103 : Employability Skills (90 Hours)

assessed/NOSs to be
assessed
Introduction to Employability PC 1. understand the significance of employability skills
Skills in meeting the current job market requirement and
future of work.
PC 2. identify and explore learning and employability
relevant portals
PC 3. research about the different industries, job market
trends, latest skills required and the available
Constitutional values - PC 4. recognize the significance of constitutional values,
Citizenship including civic rights and duties, citizenship,
responsibility towards society etc. and personal
values and ethics such as honesty, integrity,
caring and respecting others, etc.
PC 5. follow environmentally sustainable practices
Becoming a Professional in PC 6. recognize the significance of 21st Century Skills

the 21st Century for employment
PC 7. practice the 21st Century Skills such as Self-
Awareness, Behavior Skills, time management,
critical and adaptive thinking, problem-solving,
creative thinking, social and cultural awareness,
emotional awareness, learning to learn etc. in
personal and professional life
PC 8. adopt a continuous learning mindset for personal
and professional development
Basic English Skills PC 9. use basic English for everyday conversation in
different contexts, in person and over the
telephone
PC 10. read and understand routine information, notes,
instructions, mails, letters etc. written in English
PC 11. write short messages, notes, letters, e-mails etc.
in English
Career Development & Goal PC 12. identify career goals based on the skills, interests,
Setting knowledge, and personal attributes
PC 13. prepare a career development plan with short-
and long-term goals.
NSQC Approved 70
Communication Skills PC 14. follow verbal and non-verbal communication
etiquette while communicating in professional and
public settings
PC 15. use active listening techniques for effective
communication
PC 16. communicate in writing using appropriate style
and format based on formal or informal
requirements
PC 17. work collaboratively with others in a team
Diversity and Inclusion PC 18. communicate and behave appropriately with all
genders and PwD
PC 19. escalate any issues related to sexual harassment
at workplace according to POSH Act
Financial and Legal Literacy PC 20. identify and select reliable institutions for various
financial products and services such as bank
account, debit and credit cards, loans, insurance
etc.
PC 21. carry out offline and online financial transactions,
safely and securely, using various methods and
check the entries in the passbook
PC 22. identify common components of salary and
compute income, expenses, taxes, investments
etc
PC 23. identify relevant rights and laws and use legal aids
to fight against legal exploitation
Essential Digital Skills PC 24. operate digital devices and carry out basic internet
operations securely and safely
PC 25. carry out basic internet operations by connecting
to the internet safely and securely, using the
mobile data or other available networks through
Bluetooth, Wi-Fi, etc.
PC 26. display responsible online behavior while using
various social media platforms
PC 27. create a personal email account, send and
process received messages as per requirement
PC 28. carry out basic procedures in documents,
spreadsheets and presentations using respective
and appropriate applications
PC 29. utilize virtual collaboration tools to work effectively
NSQC Approved 71
Entrepreneurship PC 30. identify different types of Entrepreneurship and
Enterprises and assess opportunities for potential
business through research
PC 31. develop a business plan and a work model,
considering the 4Ps of Marketing Product, Price,
Place and Promotion
PC 32. identify sources of funding, anticipate, and
mitigate any financial/ legal hurdles for the
potential business opportunity
Customer Service PC 33. identify different types of customers and ways to
communicate with them
PC 34. identify and respond to customer requests and
needs in a professional manner
PC 35. use appropriate tools to collect customer feedback
PC 36. follow appropriate hygiene and grooming
standards
Getting ready for PC 37. create a professional Curriculum vitae (Résumé)
apprenticeship & Jobs PC 38. search for suitable jobs using reliable offline and
online sources such as Employment exchange,
recruitment agencies, newspapers etc. and job
portals, respectively
PC 39. apply to identified job openings using offline
/online methods as per requirement
PC 40. answer questions politely, with clarity and
confidence, during recruitment and selection
PC 41. identify apprenticeship opportunities and register
for it as per guidelines and requirements
the Qualification.
fill in the blanks, tick the odd man out, choose the
correct option, choose the best answer, True or false,
Identify the object, tool or machinery, arrange in proper
the trainee. Thus, section wise calculation of marks
NSQC Approved 72
questions.
situations.
questions, and decision-making based questions based
on the project report
subject.
NSQC Approved 73
answers to be expected from trainee. This reduces
effect of subjectivity of the assessor. Comparative
quality of trainees with in a batch or different institutes
can be gauged
Pass/Fail
will not be there, the aggregate pass marks for Digital Written test for knowledge
NSQC Approved 74
Title of Component: 8. LFS/N0120 v2.0: Establish own enterprise and perform
various entrepreneurial activities to run the business operations in Life Sciences
Sector

assessed/NOSs to be
assessed
Set up enterprise and perform PC1. perform a survey in the identified area for business
entrepreneurial activities activities to identify prospective customers and business
opportunity
PC2. identify products and/ or services and it's sources,
that match the business opportunity
PC3. develop business proposal with objective and
identified business area for registering the proposed
business as independent entity with competent
authorities
PC4. submit business proposals and feasibility plans for
securing the required funding from govt. schemes for
MSMEs like MUDRA etc. as and when needed
PC5. present the business proposal to investors and
stakeholders to gain their confidence and trust for
possible funding
PC6. ensure setting up the infrastructure and resources
for business as per approved plan and investors/
shareholders agreement
PC7. enrol into various government schemes and
programs for MSME and avail the benefits
PC8. promote the product/ services through various
means including digital promotions in line to regulations
for promotion and sale as per land of law
PC9. develop the supply chain and distribution network
PC10. maintain updated information regarding new

market trends to provide service to customers and
constantly upskill self and employees for futuristic
technologies, innovations and methodologies
Maintenance of accounts and PC11. ensure to generate a final invoice for the services
ledgers rendered/ or products sold
PC12. collect payment either in cash (as per RBI
guidelines)/ cheque/ demand draft or through online
transactions via RTGS/NEFT/UPI etc.
NSQC Approved 75
PC13. ensure accounts and ledgers are maintained for
the material supplied, payables and receivables, loan
ledgers, taxes collected and paid into government
treasury as well for wages paid and statutory benefits
like PF, ESI contribution deposited with authorities
PC14. ensure maintenance and reconciliation of a
monthly account as well as movable and immovable
assets and stock to keep track of profit/ loss as well as
periodic audit as per legal requirements
Comply with legal, regulatory PC15. comply with workplace health and safety rules
and statutory standards stipulated by local authorities
PC16. comply with rules related to taxes and licensing
regulations
PC17. comply with prevalent labour laws and keep
records for employee’s qualifications, employment as
well as trainings
PC18. comply with regulations and protocols related to
maintenance of product/ service license including the pre
conditions (if any)
PC19. comply with quality system like ISO/GMP/GLP etc
and any other rule mandated by appropriate regulatory
authorities
PC20. comply with pollution norms as per land of law
and ensure near zero pollution for a sustainable
environment and to earn carbon credits
PC21. ensure that business facility and employees are
always prepared and ready for any surprise inspection/
audit from clients/ regulatory/ statutory authorities
Qualification.
NSQC Approved 76
questions.
situations.
report
subject.
NSQC Approved 77
gauged
Pass/Fail
NSQC Approved 78
Title of Component: 9. LFS/N0121 v2.0: Maintain the critical business documents
as Entrepreneur in Life Sciences Sector
assessed/NOSs to be
assessed
Infrastructure related PC 1. ensure documentation and maintenance of
documentation records for architectural building layout like
blueprint of plant/lab, electric circuit and plumbing
layouts and safety equipment layout,
infrastructure and asset insurance and lease/rent
contracts/ sale deed (if owned facility)
PC 2. ensure documentation and maintenance of
records for all machineries, equipment and tools
installed/used in the plant/ lab unit, with
supplier/manufacturer details, manuals of all
machineries / equipment, installation and
qualification records and annual maintenance
details etc
records for engineering and maintenance of each
machinery/equipment, machine utilization,
machine performance, breakdown details,
corrective actions, spares changed,
machine/equipment condition etc
Supply Chain related PC 4. ensure documentation and maintenance of
documentation records for all raw materials, ingredients and
packaging materials handled, like name of the
supplier, batch details, quantity supplied and
quality of the materials supplies etc as well as
records for each supplier quality report on raw
materials, ingredients, packaging materials,
internal and external quality report on finished
products, consumer and customer complaints,
corrective actions, legal documents (if any)
records for storage facility, like condition of
storage facility, storage parameters if any like
temperature, humidity, pressure (as applicable),
space utilised, stacking procedure etc
records for distribution details like transport
NSQC Approved 79
details, quality, hygiene and cleanliness of
vehicle, quantity loaded in the vehicle, distribution
routes , outlet details, customer/ consumer details,
distribution quantity, quantity returned etc.
Documentation for sales & PC 8. ensure documentation and maintenance of
marketing records for long term and short term business
plans, feasibility reports, investor/shareholder
agreements and disbursement and payment
records for loan/grant/equity etc.
records for promotion schemes, free samples,
funding for continuing education of consumers,
customer/consumer details, product launch
strategies, quantity marketed and outcome of
marketing
records for sale like customer details, customer
type, location, quantity purchased by each
stockist/consumer, frequency of purchase, sale
details like quantity of products/brand sold in each
territory
Quality audit and PC 11. ensure documentation and maintenance of
client/regulatory inspections records for internal/ external audits with its
related documentation observations, notices/ feedback, action reports
and final submission of audit action reports
records for every communication sent to or
received from regulatory/ licensing authorities
Qualification.
NSQC Approved 80
questions.
situations.
report
subject.
NSQC Approved 81
trainees within a batch or different institutes can be
gauged
Pass/Fail
will not be there, the aggregate pass marks for Digital Written test for knowledge
NSQC Approved 82
NSQF Qualification File Approved in 21st NSQC, dated- 28/07/22
SECTION 2
25. EVIDENCE OF LEVEL
Tittle/Name of the qualification/Component: Associate- Regulatory Affairs and Intellectual Property (IVD and Medical
Devices) Level: 5
NSQF Domain Key requirements of the job role How the job role relates to the NSQF NSQF level
level descriptors
Process Few of the job elements, expected to be performed by Associate- Regulatory Affairs and 5
Associate- Regulatory Affairs and Intellectual Property Intellectual Property (IVD and Medical
(IVD and Medical Devices) are: Devices) prepares dossiers to support
● Operating the Regulatory Systems appropriate licensing, marketing and
● Regulatory Dossier Submission legal compliance of products and
● IPR Management ensure products comply with current
● Adhere to health and hygiene protocols regulations. The job role holder carries
● Adhere to safety and security procedures out proper documentation and reporting
● Adhere to emergency procedures for dossier preparation.
● Coordination with Manager He/she is also responsible to perform
● Coordination with R&D Team continuous reporting and
● Coordination with cross-functional teams documentation at every step. All the
● Coordination with External Stakeholders and above performance outcomes are
Regulatory Agencies routine and common in all the work
● Sensitivity towards all genders and people with assigned to Associate- Regulatory
disability Affairs and Intellectual Property (IVD
● Regulatory Dossier Preparation and Medical Devices), hence they are
● Regulatory compliance for labelling and inserts categorized as familiar and predictable
● Regulatory facilitation for Licences and processes where the Associate-
Authorization Regulatory Affairs and Intellectual
● Regulatory facilitation for Miscellaneous Approvals
NSQC Approved 83
● Regulatory facilitation for Licences and Property (IVD and Medical Devices) has
Authorization a situation of clear choice.
● Regulatory facilitation for Post Approval Changes
● Regulatory facilitation for US Market
● Regulatory facilitation for Indian and Other Market
● Ensuring consistent, efficient and quality
processes to meet deliverables
● Set up enterprise and perform entrepreneurial
activities
● Maintenance of accounts and ledgers
● Comply with legal, regulatory and statutory
standards
● Infrastructure related documentation
● Supply Chain related documentation
● Documentation for sales & marketing
● Quality audit and client/regulatory inspections
related documentation
Professional Few of the job elements, expected to be performed by Associate- Regulatory Affairs and 5
Knowledge Associate- Regulatory Affairs and Intellectual Property Intellectual Property (IVD and Medical
(IVD and Medical Devices) are: Devices) needs to have the factual
● Operating the Regulatory Systems knowledge of facts, principles,
● Regulatory Dossier Submission processes and general concepts related
● IPR Management to Good Laboratory Practices (GLP),
● Adhere to health and hygiene protocols how to routinely perform pre-analysis
● Adhere to safety and security procedures checks laboratory investigations and
● Adhere to emergency procedures analysis, routine Inspection of
NSQC Approved 84
● Coordination with Manager Instruments, identification of non-

● Coordination with R&D Team conformities and labelling by recalling
● Coordination with cross-functional teams the work safety guidelines. The job
● Coordination with External Stakeholders and holder should also be efficient to
Regulatory Agencies coordinate with Manager, colleagues
● Sensitivity towards all genders and people with and auditors to meet the communication
disability needs to fulfil work requirements of
● Regulatory Dossier Preparation Associate- Regulatory Affairs and
● Regulatory compliance for labelling and inserts Intellectual Property (IVD and Medical
● Regulatory facilitation for Licences and Devices)
Authorization
● Regulatory facilitation for Licences and
Authorization
activities
standards
NSQC Approved 85

Professional Few of the job elements, expected to be performed by To perform the tasks of Associate- 5
Skills Associate- Regulatory Affairs and Intellectual Property Regulatory Affairs and Intellectual
(IVD and Medical Devices) are: Property (IVD and Medical Devices) the
● Regulatory Dossier Preparation job holder utilizes professional skills like
● Regulatory compliance for labelling and inserts good communication and interpersonal
● Regulatory facilitation for Licences and skills, good analytical, reasoning skills,
Authorization attention to details, critical thinking, and
● Regulatory facilitation for Miscellaneous Approvals excellent organizational skills.
● Regulatory facilitation for Licences and For routine job activities and tasks, the
Authorization Associate- Regulatory Affairs and
● Regulatory facilitation for Miscellaneous Approvals Intellectual Property (IVD and Medical
● Regulatory facilitation for Post Approval Changes Devices) uses the planning and
● Regulatory facilitation for US Market organizing skills.
● Regulatory facilitation for Indian and Other Market The scope of utilization of all above
● Ensuring consistent, efficient and quality professional skills remains limited to
processes to meet deliverables routine and repetitive and for a narrow
● Set up enterprise and perform entrepreneurial range of applications
activities
standards
NSQC Approved 86

Core Skills Few of the job elements, expected to be performed by To perform the tasks, Associate- 5
Associate- Regulatory Affairs and Intellectual Property Regulatory Affairs and Intellectual
(IVD and Medical Devices) are: Property (IVD and Medical Devices)
uses organizing information,
● Regulatory Dossier Preparation communication and problem-solving
● Regulatory compliance for labelling and inserts skills.
● Regulatory facilitation for Licences and For reporting and documentation
Authorization proposed, he/she applies the basics of
● Regulatory facilitation for Miscellaneous Approvals arithmetic and algebraic principles and
● Regulatory facilitation for Licences and organizational skills.
Authorization For coordination related tasks and
● Regulatory facilitation for Miscellaneous Approvals ensuring compliance to organizational
● Regulatory facilitation for Post Approval Changes SOPs and regulatory requirements, the
● Regulatory facilitation for US Market job holder is expected to have a basic
● Regulatory facilitation for Indian and Other Market understanding of the social-political and
● Ensuring consistent, efficient and quality natural environment at the place of
processes to meet deliverables work/ organization he/she is working
● Set up enterprise and perform entrepreneurial for.
activities
standards
NSQC Approved 87

Responsibility Few of the job elements, expected to be performed by Associate- Regulatory Affairs and 5
Associate- Regulatory Affairs and Intellectual Property Intellectual Property (IVD and Medical
(IVD and Medical Devices) are: Devices) has responsibility for his/her
● Operating the Regulatory Systems work and learning and supports to
● Regulatory Dossier Submission Biologist- Quality & Research and
● IPR Management Chemist - IP/QA and cross functional
● Adhere to health and hygiene protocols Teams. And in case of a
● Adhere to safety and security procedures scenario/situation of no clear choice, he
● Adhere to emergency procedures is expected to take guidance from the
● Coordination with Manager Head of Quality Department.
● Coordination with R&D Team
● Coordination with cross-functional teams
● Coordination with External Stakeholders and
Regulatory Agencies
● Regulatory Dossier Preparation
● Regulatory compliance for labelling and inserts
Authorization
Authorization
NSQC Approved 88

activities
standards
NSQC Approved 89
SECTION 3
EVIDENCE OF NEED
26 What evidence is there that the qualification is needed? What is the
industry relevance of this qualification and what is the basis of this?
Need of the LSSSDC has prepared a skill gap report

qualification forecasting the need for this job role both on a
short-term and long-term basis.
Additionally, all the industries that have validated
the qualification have expressed the need for this
qualification considering the futuristic need.
Industry Experts from following companies have consented

Relevance for relevance of this qualification with Industry
need.
S.No Name of Organization

1 SHRM Biotechnologies Pvt Limited
2 Tirupati Wellness Pvt Ltd.
3 Sarv Pharmaceuticals
4 Nakoda Chemicals Limited
5 Diverse Genomics Pvt Ltd.
6 Emcure Pharmaceuticals Limited
7 Biocon Biologcs Ltd
8 Kumar Organic Products Ltd.
9 Blue Cross Laboratories Pvt Ltd.
10 Smruti Organics Limited
11 Group Pharmaceuticals Ltd
12 MJ Biopharm Pvt Ltd
13 Arbro Pharmaceuticals Private Limited
14 Anglo-French Drugs & Industries Ltd
15 Neuland Laboratories Ltd.
16 Zydus Lifesciences Ltd.
17 Belco Pharma
18 Unimarck Healthcare Ltd.
19 Pure & Cure Healthcare Pvt.Ltd
20 Drugfarm Laboratories
21 Tirupati Medicare Ltd
90
Usage of LSSSDC would submit periodic details (directly/Via

qualification NSDC) of the employment generated (wherever
applicable) and realize under training in the
Qualifications post-approval of NSQC and
implementation of the qualification.
Estimated uptake LSSSDC has prepared a skill gap report
forecasting the year wise estimated uptake. The
forecasted uptake is given as annexure 4.
27 Recommendation from the concerned Line Ministry of the

Government/Regulatory Body. To be supported by documentary
evidence
We have requested a recommendation from the Ministry of Health and

Family Welfare as well as Department of Biotechnology for the job role of
Associate- Regulatory Affairs and Intellectual Property (IVD and Medical
Devices)
. (Copy of request letter is enclosed in Annexure 5). The response from both
the Ministries is awaited and will be submitted sooner we receive it.
28 What steps were taken to ensure that the qualification(s) does (do) not
duplicate already existing or planned qualifications in the NSQF? Give
justification for presenting a duplicate qualification
Before submission of the qualification to NSQC we have checked the
availability of Associate- Regulatory Affairs and Intellectual Property (IVD
and Medical Devices) with other councils on the portal of NSDC and we
found no other qualification matching with the submitted job role. We have
revalidated the first version of NSQC approved Qualification of Associate-
Regulatory Affairs and Intellectual Property (IVD and Medical Devices)
earlier named as Drug Regulatory Affairs Chemist from Life Sciences Sector
Skill Development Council. Hence no duplication is found of the submitted
job role. While performing the functional analysis approved by industry, we
identified skill gap in some competencies and NOSs which have been
rewritten and revalidated from industries. We have revised the qualification
to give electives. The validation mails and inputs received from industries as
one of the evidence. Hence following NOS have been newly drafted for the
revised Qualification of Associate- Regulatory Affairs and Intellectual
Property (IVD and Medical Devices) considering this to be an emerging area
and the requirement of future skills in fresh aspirants. New mandatory
employability skills NOS has been added as per the guidelines from NCVET:
91
1. LFS/N0570 v2.0: Development of Technical Dossier as per the

regulatory guidelines of intended market (India and Global) for
Medical Devices and In-vitro Diagnostic Devices (IVD)
2. LFS/N0502 v3.0: Submission of Technical Dossier as per the
3. LFS/N0569 v2.0: Assist in managing the regulatory affairs for Medical
Devices and In-vitro Diagnostic Devices (IVD)
4. LFS/N0571 v2.0: Assist in intellectual property rights management for
life sciences products and assets
5. LFS/N0567 v2.0: Coordinate with R&D team, other cross-functional
teams, external stakeholders and regulatory agencies to manage
regulatory affairs operations
6. LFS/N0122 v2.0: Ensure adherence to Environment, health and
safety guidelines at workplace by self and subordinates
7. DGT/VSQ/N0103: Employability Skills (90 Hours)
8. LFS/N0120 v2.0: Establish own enterprise and perform various
entrepreneurial activities to run the business operations in Life
Sciences Sector
9. LFS/N0121 v2.0: Maintain the critical business documents as
Entrepreneur in Life Sciences Sector
29 What arrangements are in place to monitor and review the
qualification(s)? What data will be used and at what point will the
qualification(s) be revised or updated? Specify the review process here
Workshops with Industry Associations of Employers are part of a continuous
awareness drive and will be utilized as a channel to get continual feedback
from Industry as this is an emerging area as future skills and its important to
closely track the demand of employment and industry growth.
LSSSDC will be engaged with Training Providers, Authorised educational
institutions and higher education institutions (under AICTE and UGC), who
are imparting training as per qualification guidelines, to gather feedback in
implementation
Monitoring of candidate Assessment Result will be carried out
Employer feedback will be sought post placement of trainee’s batch
A formal review is scheduled in a three-year time frame
92
SECTION 4
EVIDENCE OF PROGRESSION
30 What steps have been taken in the design of this or other

qualifications to ensure that there is a clear path to other
qualifications in this sector?
Show the career map here to reflect the clear progression
Mobility options to other qualifications are enabled through the alignment of

educational qualifications and prior work experience stated as a
requirement in the respective qualifications. For Example:
After 3-4 years of Industry work experience Associate- Regulatory Affairs

and Intellectual Property (IVD and Medical Devices) post-qualifying the
certification for Associate- Regulatory Affairs and Intellectual Property (IVD
and Medical Devices), a candidate has an option to qualify for various job
roles as an upward progression such as :
1. Specialist- Quality Assurance (Pharma, Biological Products and
Medical Devices) (Level 5)
Also, a qualified Associate- Regulatory Affairs and Intellectual Property
(IVD and Medical Devices) has option to move for horizontal progression
across Sector in Process Industries like
1. Associate- Regulatory Affairs and Intellectual Property (Level 5)
2. Chemist - IP/QA (Level 5)
A qualified Associate- Regulatory Affairs and Intellectual Property (IVD and

Medical Devices) can also set up his/her own enterprise as a regulatory
affairs consultant.
93

Qualification File - Associate - Regulatory Affairs and Intellectual Property (IVD and Medical Devices)

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Qualification File - Associate - Regulatory Affairs and Intellectual Property (IVD and Medical Devices)

Uploaded by

Copyright:

Available Formats

Qualification Code

NSQF Qualification File

CONTACT DETAILS OF THE BODY SUBMITTING THE QUALIFICATION FILE

Name and address of submitting body:

Name and contact details of individual dealing with the submission

List of documents submitted in support of the Qualifications File

Model Curriculum (attached as annexure) including the following:

Research and Development

Total Notional Hours =600 Hours

Notional Hours for Optional Module

Min Notional Hours: 600 Hours

14 Indicative list of training tools Attached as annexure 2

15 Entry requirements and/or B. Tech Final Year Student (in Relevant

Min Age: 21 Years

South Africa NOS

Compulsory Bridge Module 30:00 Level-5 1.00

NOS/ Module Details Total Level

Total Maximum Duration of Notional Hours 660:00

Recommended Apprenticeship Duration 6 Months

Following assessment agencies will carry out assessments:

Assessment process for RPL programs (Candidates with experience in the

Assessment tools: For the Training assessment, the assessment instrument

Digital Written test for knowledge assessment:

Digital Written test for skill assessment

Following assessment agencies will carry out assessments:

Assessment Agencies: An assessment agency is selected based on

Assessment development: The assessment development is done with close

Assessor: The Assessors are engaged to conduct the assessments.Assessor

Graduate B.Pharma 6 Regulatory 2 On the job

M.Pharma 4 Regulatory 2 On the job

Assessment tools: Assessment tools for a qualification are decided based on

Digital Written test for knowledge assessment:

Digital Written test for skill assessment

Assessment process for Apprenticeship linked fresh skill development

Part 1: OJT Assessment

1.1 Industry nominated aassessor:

1.2 Assessment Tool for OJT:

1.2.1 OJT Monitoring Report:

Method – Direct questions open and close ended questions, situation-based

Analysis – Assessor draws a spectrum of ready answers to be expected from trainee.

1.3 Execution of OJT Assessment:

Part 2: Basic Training Assessment

2.2 Assessment tool for Basic Training:

2.2.1 Digital Written test for knowledge assessment:

Tools –computer or tab based online or offline.

Analysis – Question paper is divided in sections. Each Section intends to assess a

2.2.2 Digital Written test for skill assessment:

Tools – computer or tab based online or offline questions

Analysis – Question paper is divided in sections. Each Section intends to assess a

2.3 Steps for assessment development:

2.4 Execution of Basic Training Assessment:

2.4.1 Tab based assessment using physical proctoring

2.4.1 Tab-based assessment using physical proctoring

2.4.2 Smart phone-based assessment using e-proctoring

● LSSSDC Protocol for Accreditation of Assessment Agencies and Assessment

1. LFS/N0570 Regulatory Dossier Preparation 15 30 10 5

device (IVD) as per

information leaflet (PIL),

Operating the Regulatory 20 30 9 2

tracking the application

PC8. prepare and submit

PC10. prepare and submit

PC4. facilitate for submission of