Senior Regulatory Compliance Specialist

1 week ago


Alwar, Rajasthan, India beBeeRegulatoryAffairs Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Regulatory Affairs Professional

  • Manage regulatory activities for submissions, including preparation and filing of regulatory documents.
  • Oversee compilation and submission of annual reports, amendments, and deficiency responses.
  • Collaborate 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 product and process compliance with regulatory requirements.
  • Stay updated on evolving regulations and provide strategic guidance.

Key Requirements:

  • 7–10 years of 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 technical documents: Module 2 & 3 (CTD format).
  • Exposure to quality systems and BMR review.
  • Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with the FDA.


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