B.Pharma / M.Sc
Position: Regulatory Affairs Sr. Manager / AGM
Location: [Location not specified]
Qualification: B.Pharma / M.Sc
Experience: 10–22+ years in API formulation
Key Responsibilities:
- Preparation and Review:
- High-quality Drug Master File (DMF) and Certificate of Suitability (CEP) applications for APIs.
- Submission to QM, USFDA, and global regulatory authorities.
- Expertise in Fermentation and Biotechnological APIs:
- Preparation and review of DMFs specific to these API types.
- Process and Analytical Review:
- Review of process validation, analytical method validation, and stability protocols/reports with a focus on regulatory implications.
- Customer Communication:
- Providing open part DMFs, technical packages, and query responses for global product registration.
- Timely Submissions:
- Annual reports, amendments (US), CEP variations, and ASMF amendments (EU) for registered drug substances.
- Vendor Development Support:
- Detailed specification review and adherence to registration commitments.
- Post-Approval Changes:
- Change control review and submission of post-approval changes to relevant DMFs and regulatory bodies.
- Regulatory Knowledge:
- Familiarity with FSSAI License, BRC, ISO 22000, FSSC 22000 certification.
- Preparation and management of documents for Halal and Kosher certifications.
How to Apply:
Send your CV to Jai.mirchandani@symbiotec.in
