Symbiotec Pharmalab is currently hiring for a Manager position in the Regulatory Affairs department. This role is ideal for professionals with expertise in regulatory compliance,
Symbiotec pharmalab hiring details:
REGULATORY AFFAIRS MANAGER
REQUIRED JOB PROFILE-:
– Qualification-: B.Pharma/M.Sc with 5 – 10 years of Experience in API formulation.
1. Preparation, review and submission of high quality Drug Master File and certificate of suitability applications for Active Pharmaceutical Ingredients for submission to QM, 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 customers 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 FSSAl License, BRC, ISO 22000 and FSSC 22000 certification and preparation of documents and managing the application process for Halal and Kosher Certifications.
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