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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:

  1. 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.
  2. Expertise in Fermentation and Biotechnological APIs:
    • Preparation and review of DMFs specific to these API types.
  3. Process and Analytical Review:
    • Review of process validation, analytical method validation, and stability protocols/reports with a focus on regulatory implications.
  4. Customer Communication:
    • Providing open part DMFs, technical packages, and query responses for global product registration.
  5. Timely Submissions:
    • Annual reports, amendments (US), CEP variations, and ASMF amendments (EU) for registered drug substances.
  6. Vendor Development Support:
    • Detailed specification review and adherence to registration commitments.
  7. Post-Approval Changes:
    • Change control review and submission of post-approval changes to relevant DMFs and regulatory bodies.
  8. 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

Symbiotec Pharmalab Hiring Regulatory Affairs
Symbiotec Pharmalab Hiring Regulatory Affairs
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