Regulatory Affairs Executive (Sun Pharma)

Roles and Responsibilities

Area of Responsibility

1.New submissions/Renewals:

a.Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.

b.Review documents (Development report, scale up report, specification, stability protocol), artworks etc. before initiation of Exhibit batches for adequacy.

2.Approval:

Review & prepare response to deficiency enabling approval of products filed to regulatory agency.

3.Lifecycle management for drug formulations:

a. Prepare and review variations as per the country specific requirements to support approval of changes such as API

vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.

4.Regulatory compliance:

a. Prepare, Review and circulate approval package with product history sheet to stake holders upon receipt of approval and updatethe same based on queries and variations.

b. Ensure reposition of comprehensive product information into central repository

C. Review regulatory filing impact of variations, change controls, etc.

5 Geographic Scope/ Market :South Africa

Travel Estimate

NA

Job Requirements

Educational Qualification

Graduate : M.Sc /M.Pharm

Experience

Tenure: 1-4 years