Senior Compliance Manager

1 week ago


Hubli, Karnataka, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 2,00,00,000

Key Responsibilities:

  • Lead and manage CMC regulatory activities for submissions, including ANDA preparation, review, and filing.
  • Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Interface with cross-functional teams 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 regulations and provide impact assessment and strategic guidance.

Key Requirements:

  • 7-10 years of experience in Regulatory Affairs – CMC with USFDA filings.
  • 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.


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