Symbiotec Hiring For Regulatory Affairs Dept
Position: Sr. Manager/AGM - Regulatory Affairs
Location: Specify Location
Qualifications: B.Pharma/M.Sc
Experience: 10-22+ years in API formulation
Key Responsibilities:
1. Prepare, review, and submit high-quality Drug Master Files and certificate of suitability applications for Active Pharmaceutical Ingredients for submission to QM, USFDA, and other global regulatory authorities.
2. Expertise in the preparation and review of Drug Master Files for fermentation and biotechnological-based APIs.
3. Review process validation, analytical method validation, stability protocols, and reports with a special emphasis on regulatory ramifications.
4. Communicate effectively with customers by providing open part DMF, technical packages, and query responses to ensure product registration worldwide.
5. Ensure timely submission of annual reports and amendments in US, CEP variation/ASMF amendments in the EU for registered drug substances.
6. Participate in vendor development assignments with respect to the exact and precise denomination of product specifications and registration commitments.
7. Review change control and submission of post-approval changes to respective Drug Master Files and countries.
8. Knowledge of FSSAI License, BRC, ISO 22000, and FSSC 22000 certification. Manage the application process for Halal and Kosher Certifications.
How to Apply:
Send your CV to: jai.mirchandani@symbiotec.in
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| Symbiotec Hiring For Regulatory Affairs Dept |
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