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.

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