CURRICULUM VITAE

Mr. Baliram Dnyaneshwar Taur

M.S. (Pharm.) Pharmacology & Toxicology,
National Institute of Pharmaceutical
Education and Research (NIPER), Hyderabad.

Permanent Address: Correspondence Address:

At-Changatpuri Tq-Partur Balanagar, Hyderabad.
District-Jalna (Maharashtra) Pin Code: 500037
Phone: +91 9960724088
Email: taurbaliram@gmail.com

CAREER OBJECTIVE

To achieve excellence in working as dynamic professional having around 5 years of experience in

Regulatory Affairs, where my analytical ability and analysing quest are used for maximum growth of the
organization, and to grow with the organization. Seeking a challenging position in well-established
company that offers professional growth and ample opportunity to learn and enrich my competencies in
my profession.

ASSETS

Self-motivated dynamic individual who emphasizes knowledge sharing for improved productivity,
Efficiency and cost effectiveness. Possess strong analytical, creative thinking, problem solving and
communication skills.

PROFESSIONAL PORTFOLIO (Current)

Organization : Parexel International, Hyderabad

Designation : Regulatory Affairs Associate
Specialization : Regulatory Affairs
Period : September 2021 - Till date
Nature of Business : Parexel is one of the world's leading global clinical research organizations and
biopharmaceutical services company headquartered in United States.
Web Address : www.parexel.com

PROFESSIONAL PORTFOLIO (Previous)

Organization : Intas Pharmaceuticals Limited, Ahmedabad
Designation : Research Associate-II
Specialization : Regulatory Affairs
Period : March 2020 – August 2021
Nature of Business : Intas is a leading, vertically integrated global pharmaceutical formulation
development, manufacturing and marketing company headquartered in
Ahmedabad, India.
Web Address : www.intaspharma.com

PROFESSIONAL PORTFOLIO (Previous to Previous)

Organization : Aurobindo Pharma Limited, Hyderabad

Designation : Research Associate
Specialization : Regulatory Affairs
Period : June 2018 - February 2020
Nature of Business : Aurobindo Pharma Limited is a pharmaceutical manufacturing company
 headquartered in HITEC City, Hyderabad, India. The company manufactures
generic pharmaceuticals and active pharmaceutical ingredients.
Web Address : www.aurobindopharma.com

JOB PROFILE - PAREXEL INTERNATIONAL, HYDERABAD (Market: Europe)

• Responsible for Submission of Safety, Quality and Administrative variations as per EMA
committees recommendations as per timelines of Type IA, IAin, IB, Type II variation
• Submission of Supergrouping and Worksharing procedure variations as per Client requirements
• Hands on experience in preparation of Module 1 to Module 3 for different procedures like
Centralised procedure, DCP, NATIONAL and MRP for variation submission
• Preparation and review of Query Responses
• Hands on experience in preparation of Renewal, withdrawal, safety variations, MAH
transfer/RMS transfer and administrative variations
• Performing self QC checks to ensure the high quality of submission
• Initiation of Translation request (French to English and Spanish and Vice Versa), In relation to
MA/License approval and potential commitments
• Proficient in handling various Regulatory tools such as Veeva Vault (RIMS)
• Responsible for updating, archiving and managing RIMS tools for different activities like
variation, renewal, withdrawal, MAA approval, license update and other updates for EU market
• Veeva Vault ‐ Experienced in uploading documents/ archiving of published outputs and life cycle
maintenance of the products and dispatch submission package and updating other administrative
information in Veeva Vault
• Responsible to submit variations using Veeva Vault software by creating RO's, Binders,
submission records and core Packages
• Responsible for keeping the track of dispatched documents for various submissions and post
approval commitments
• Hands on experience on IRIS Portal to Transfer a Research Product Identifier (RPI)
• Coordination with the Client team for the timelines and other activities for the admin documents
• Coordination and interaction with Clients in a weekly basis meeting
• Performed a role as a Parexel Co-Ordinator to set up Kick of Meeting (KOM)/ Ad-hoc Meeting
with Client Based upon Variation Submission requirement

JOB PROFILE - INTAS PHARMACEUTICAL LIMITED (Market: Europe)

• Responsible for the preparation and compilation of registration dossiers for EU countries in eCTD
format via procedures (CP, DCP, MRP and NP) for parenteral dosage forms as per dated timeline
• Responding to the queries arose by regulatory authorities in time and accomplishes interactions
with included Reference member State (RMS) and Concerned member state (CMS) during the
authorization phase (DCP/MRP Day Responses) as per prescribed time table to get quick
approvals
• Co-ordination and timely follow up with cross functional teams for the collections of documents
required for dossier filing
• Review of CMC documents such as PDR, MPCR, Specifications-MoA, Stability protocols,
Stability data, BMR, Process Validation (Protocols and Reports) of manufacturing process,
CEP/ASMF applicant part etc.
• Familiar with scientific quality regulatory guidelines of ICH
• Experience of working in close liaison with cross functional teams including those of Product
development, Manufacturing, Quality Assurance, Commercial and regulatory counterparts in
affiliate companies/partners and various clients (Switzerland and Balkan countries)
• Regular tracking of received & pending documents from cross functional teams
• Act as contact point/knowledge base for scientific and technical aspects for Module 1
(Administrative including labelling) and Module 3 (CMC) documents and associated regulatory
activities
 • Preparation of Cover letter, Application form as per EU requirements
• Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL) &
Labels as per QRD for different type of applications like CP, DC, MR & National Procedures
• Preparation of Mockups, artworks for EU countries as per Blue box requirements
• Preparation of bridging reports to waive the Readability test reports
• Hands on Live experience of multiple internal systems like PharmaREADY, EMA submission
portal, Lorenz Validator, CESP, Infarmed and other national submission portal
• Transferring Registration transfer details (RTD) to plant of registered product based upon quick
approval for commercial requirements of product
• Filing & Submission of safety, quality and administrative variations as per EMA committees
recommendations as per timelines of Type IA, IAin, IB and Type II variation
• Timely submission of response/justification to RSI/RFI as received from agencies of respective
variations
• Responsible to review Product Approval Package (PAP) for self and customers based on initial
approval, renewal & variations
• Responsible for technical clearance of proposals received from R&D/Mfg. site, vendors, SCM
etc. (Identification of changes during site transfer proposals, Method/Process Changes,
Submission of new ASMF/CEP, Shelf-life extension, Pack size/Type additions, Batch size range,
Change in Specification/Method of analysis, CEP/ASMF updates etc.)
• Working with specialist Software’s and resources such as PharmaREADY (Sequence compilation
to till publishing sequence for new MAA as well as variation packages for European Union
Countries in eCTD formats), SAP integration for batch manufacturing details and compliance,
QMS for Change controls related activity
• Product life cycle management & maintenance of filing database
• Commercialization of product of interested countries in European union
• Regulatory and Documentation functions which includes updating Filing status of Dossier as per
specific country guidelines

JOB PROFILE - AUROBINDO PHARMA LIMITED (Market: Europe)

For initial submissions:

• Compilation of fully integrated sections of Module-1, Module-2 and Module-3 in eCTD format
for preparation of marketing authorization in European Union countries for various submissions
(DCP, MRP, National procedures to Marketing Authorizations) for different types of dosage
forms (solid and parenteral)
• Review of documents such as Specifications, Stability protocols, Stability data, BMR, BPR,
Validation Protocols and Validation Reports of manufacturing process
• Familiar with scientific quality regulatory guidelines of ICH
• Experience of working in close liaison with cross functional teams including those of Product
development, Manufacturing, Quality Assurance, Commercial and regulatory counterparts in
affiliate companies/partners
• Responding to the queries arose by regulatory authorities in time and accomplishes interactions
with included Reference member State (RMS) and Concerned member state (CMS) during the
authorization phase (DCP/MRP Day Responses) as per prescribed time table to get quick
approvals
• Preparation of Cover letter, Application form as per EU requirements
• Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL) &
Labels as per QRD for different type of applications like DC, MR & National Procedures
• Preparation of Mockups, artworks for EU countries as per Blue box requirements
• Preparation of bridging reports to waive the Readability test reports
• Review and Submission of dossiers in electronic format (eCTD) for Marketing Authorizations,
Variations and Renewals through various portals and platforms (e.g.: CESP and UK portals) as
per EU Specifications
Post-approval activities:
• Filing & Submission of Safety, Quality and Administrative variations as per EMA committees
recommendations as per timelines of Type IA, IAin, IB and Type II variation
• Maintaining the routinely Article 57 database (XEVMPD) entries like Initial, Update,
Invalidation & Nullification on each authorised medicinal products
• Execution of artworks based on post approvals with clear work order revision (WOR) and change
controls
• Working with specialist Software’s and resources such as PharmaREADY (Dossier approval
Information publishing (DAI), AGILE for artworks approval, QMS for Change controls related
activity, Text verification tool (TVT) for artworks checking
• Product life cycle management & maintenance of filing database
• Commercialization of product of interested countries in European union
• Acquiring & MA Transfer of around 3000 Marketing Authorizations (MAs) of Crossbow
countries (BE, NL, LU, FR, ES, IT, DE, PT) from Actavis to AUROBINDO
• Regulatory and Documentation functions which includes updating Filing status of Dossier as per
specific country guidelines

GREATEST ACHIEVEMENT

• Recognized by Manager in Discretionary program for the Quality of Work and Continuous Team
Collaboration in the Category of Quality at Parexel International, Hyderabad
• Recognized by Client in Discretionary Confidential Survey for Quality of Work on Submission
Project at Parexel International, Hyderabad

COMPUTER PROFICIENCY

• Well Versed with MS Office such as Word, Excel, Power Point and Adobe Acrobat XI Pro
• Hands on Databases (USFDA / EU) and Resources for Industry, PharmaREADY, CESP, EMA
gateway, Lorenz eValidator, SAP and various softwares

ACADEMIC CREDENTIALS

Sr. No Description Board/University Year Percentage/C.G.P.A

1 M.S. (Pharm) Department National Institute of Pharmaceutical 2016-18 8.16
of Pharmacology & Education and Research (NIPER),
Toxicology Hyderabad
2 B.Pharmacy Nanded Pharmacy College, Nanded 2012-16 71.25
(Maharashtra)
3 Class XII Maharashtra State Board 2011-12 75.00
4 Class X Maharashtra State Board 2009-10 87.45

DISTINCTIVE HIGHLIGHTS

• Qualified NIPER-JEE 2016 AIR-172

• Qualified GPAT-2016 AIR-1182

ACADEMICS RESEARCH PROJECT

• Completed Research project based upon topic “Targeting Heat Shock Protein-90 (HSP-90) for the
treatment of Breast Cancer” under Guidance of Dr.Venu Talla, Lecturer (Department of
Pharmacology and Toxicology) at NIPER Hyderabad

WORKSHOPS AND CONFERENCES

 • Attended Virtual Conference which was conducted by Indian Society for Clinical Research
(ISCR-2021) on Topic “Connecting Global Regulatory Submission Strategy and CTD
Components” between 10th -11th December 2021
• Participated in short term online course entitled “Awareness Course on Recent Changes in Indian
and Global Regulatory Lnadscape” organized by NIPER Hyderabad on 29 March 2022 (Won Best
Participant Certificate from NIPER Hyderabad in the exciting event)
• Attended Conference and Presented a Poster on Topic “Cardioprotective effect of methanolic
extract of Cassia tora and its active constituents Emodin on 5-Flurouracil induced cardiotoxicity in
rats” in Annual Conference of Indian Pharmacological Society 2017 (IPSCON-2017) which was
organised by SVKM’S NMIMS University, Mumbai (15 Feb to 17 Feb 2018)
• Attended Conference on “Drug Discovery and Developement Focus on Cancer and Diabetes” at
NIPER, Hyderabad (March 2017)
• Attended Conference on “Innovation in Pharmaceutical Techniques and Workshop on GLP/GMP
Compliance” at NIPER Hyderabad (January 2017)
• Attended Conference on “Quality Management in Bulk Drug and Formulation Manufacturing” at
NIPER Hyderabad (August 2016)
• Attended Seminar on “Promotion of Generic Medicine” at Governement Gandhi Medical College,
Hyderabad

EXTRACURRICULAR ACTIVITY

• Participated in donation campaign globally to fight against the Novel Coronavirus (COVID-19)
pandemic disease in India through PM CARES Fund
• Participated in a Goonj (Non-Profit Organization headquartered in Delhi, India) programs on
behalf of AUROBINDO Pharma Limited on 1 January 2020 to assist them as helping hands in
terms of disaster relief, humanitarian aid and community development
• Participated in Singing competition conducted by NIPER Hyderabad & received reward with best
compliments from Honourable Director Dr.U.S.N.Murty, NIPER Hyderabad (15th August 2016)
• Participated in HIV-AIDS awareness programme organised by NIPER Hyderabad

PERSONAL DETAILS

Name : Baliram Taur

Permanent address : At-Changatpuri Tq-Partur District-Jalna (Maharashtra)
Date of Birth : 05/02/1995
Nationality : Indian
Gender : Male
Marital status : Married
Father’s Name : Dnyaneshwar Taur
Mother’s name : Vandnabai Taur
Languages Known : English, Hindi, Marathi
Hobbies : Singing songs, Reading spiritual books and Newspapers etc

DECLARATION

I hereby declare that the information furnished above is correct to best of my knowledge.
Date:
Place: Hyderabad, India (Baliram Taur)