Posted:None|
Platform:
Work from Office
Full Time
Hi,
We have opening for the position of API regulatory affairs department for API Manufacturing industry.
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
Experience - 05 to 12yrs,
Education: M.Sc- Chemistry
Preferred only API Pharma industry experience profile.
Interested candidate can share their profile on email id amrutar@harmanfinochem.com
Harman Finochem
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