POPULAR PHARMACEUTICALS LTD.

JOB DESCRIPTION
` Job Grade E-3 Revision No. Page 1 of 2

Title

Approved By Date

Job Title: Executive, Regulatory Affairs Department: Regulatory Affairs

Reporting to: Md. Zakir Hossain Location: PPL Head Office
Name of Job Holder: Muhammad Abdul Gaffar Employee ID # P07292

Job Purpose: Ensuring the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and
medical products in order to control their safety and efficacy.
Scope:

Main Tasks and Responsibilities:

Rank Description
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory
1 pathways, compliance test requirements, or clarification and follow-up of submissions under review
for Biological/Vaccine/Biosimilar products.
Provide technical review of data or reports that will be incorporated into regulatory submissions to
2
assure scientific rigor, accuracy, and clarity of presentation.
Review adverse drug reactions and file all related reports in accordance with regulatory agency
3
guidelines.
4 Communicate with DGDA Officials for Bio-Similar products registration.

5 Submission of all application and communication with DLS officials for getting the NOC approval

6 Category 1 and Category 2 license renew from DLS Head office

Communicate with Narcotic Officials, Dhaka Sub-region, Gandaria for getting the recommendation
letter for import and export permission of narcotic product. Communicate with Narcotic Officials,
7 Head Office for getting the import and export permission of narcotic product. Communicate with
Chemical Lab, Gandaria for getting the test report of narcotic product (Raw materials and Finished
products).
8 Coordinate efforts associated with the preparation of regulatory documents or submissions.

9 Analyze product complaints and make recommendations regarding their reportability.

10 Documents Evaluation of all Bio-Similar products, existing and upcoming (vaccine and hormone).

Co-ordination with supply chain and manufacturer of Bio-similar product to collect the document as
11
per QA and DGDA requirements
File prepare of Bio-Similar products for DGDA’s evaluation and submission.
12
Summary protocol compile/prepare for vaccine lot release purpose.

Co-ordination with Supply Chain (SC) and Product Development (PD) department for new product
13
QC sample approval as per new product proposal.
Co-ordination with SC and PD department for new product Development sample status as per QC
14 sample approval.

15 Co-ordination with PD department for stability study and recipe submission status.

16 Prepare Marketing Authorization (MA) Certificate and review Annexure of new product.

Co-ordination with SC and PMD for new product’s packaging materials development status.
17

Form No. HRF/003/01 Effective Date: 01/01/2016

 POPULAR PHARMACEUTICALS LTD.
JOB DESCRIPTION
` Job Grade E-3 Revision No. Page 2 of 2

Title

Approved By Date

18 Follow up all materials availability for new product production/launching.

Authority:

Interaction:

Performance Criterion:

External Relationship:

ORGANIZATIONAL FRAMEWORK:

Executive
Assistant
Manager
AGM Executive
Executive

Signature of the Job Holder: Date:

Signature of the Supervisor: Date:

Form No. HRF/003/01 Effective Date: 01/01/2016