Regulatory Compliance Manager

14 hours ago


Surat, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Job Summary:

We are seeking an experienced Regulatory Affairs Specialist to lead our CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.

  • Manage and coordinate the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Collaborate with cross-functional teams, including Quality Assurance, Production, and R&D, to gather required documentation and data.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide strategic guidance.

Requirements:

  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.


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