AGM / DGM- Regulatory Affairs

Educational Qualification : M.Sc / M.Pharm

Total Experience : 10 years onwards in fermentation API

Designation : AGM / DGM

Department : Regulatory Affairs

1. Preparation, review and submission of high quality Drug Master File and certificate of suitability applications for Active Pharmaceutical Ingredients for submission to EDQM, USFDA and Rest­ Of - World regulatory authorities.

2. Expertise to have preparation and review of Drug Master File for Fermentation and biotechnological based API.

3. To review the Process validation, Analytical method validation, Stability protocols and reports with special emphasis on regulatory ramifications.

4. Effective communication with customer by providing open part DMF, technical package, query response, to ensure the product registration throughout the world.

5. Ensure timely submission via Annual report and Amendments in US, CEP variation / ASMF Amendments in EU for the drug substances registered.

6. To participate in the vendor development assignment with respect to the exact and precise denomination of product specification and registration commitments.

7. To review change control and submission of post approval changes to respective Drug Master Files and countries.

8. Should have knowledge on FSSAI License, BRC, ISO 22000 and FSSC 22000 certification and preparation of documents and managing the application process for Halal and Kosher Certifications.

9. Providing technical support to the research and development team during new product formulations, and to the Sales and Marketing Team regarding product specifications.

10. Knowledge of facility registration and renewal with USFDA and staying current with regulatory developments and trends impacting the nutraceutical industry.

Interested candidates can reach out @jai.mirchandani@symbiotec.in