Symbiotec - AGM/DGM - Regulatory Affairs

Educational Qualification: M.Sc/ M.Pharm.

Total Experience: 10 years onwards in fermentation API.

Designation: AGM/DGM.

Department: Regulatory Affairs.

- 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.

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

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

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

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

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

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

- 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.

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

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