Role & responsibilities

1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries
2. Submission of DMF amendments and variation filings to implement the post approval changes
3. Evaluation of change controls and perform regulatory assessment based on submitted DMF
4. Co-ordinated with cross functional team such as QA, QC,production, ADL and R&D; and review of documents received for registration purpose.
5. To Maintain regulatory database by following best regulatory practices
6. To prepare action plan for Defficiency letter response and timely Respond to defficiency letters
7. To provide Best in class API regulatory support to Customer
8. Knowlege of current regulatory guidelines and ICH guidelines

Please Note: Only candidates with relevant API regulatory experience will be considered

Preferred candidate profile

Candidate with minimum 2-6 years of experience in regulatory affairs API, for compilation of USDMF, EDQM CEP, CADIFA - Brazil, Health Canada, EU-ASMF.

Life cycle management of DMF to keep the DMF up to Date. To respond to Health Authorities deficiency letter for successful approval of MAA.

📌 Officer / Sr. Officer Regulatory Affairs (API) (Mumbai)
🏢 Harman Finochem
📍 Mumbai