Senior Regulatory Compliance Expert

3 days ago


Kolkata, West Bengal, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Senior Regulatory Affairs Specialist

About the Role

We are seeking an experienced and skilled Senior Regulatory Affairs Specialist to lead our regulatory activities for USFDA submissions, including preparation, review, and filing of documents.

The ideal candidate will have a strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.

Key Responsibilities
  • Lead and manage CMC regulatory activities for USFDA submissions, including preparation, review, and filing of documents.
  • Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses to ensure compliance.
  • 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 aligns with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide impact assessments and strategic guidance.
Requirements and Qualifications
  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings, especially ANDAs.
  • A strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Experience in preparing and reviewing technical documents, including Module 2 & 3 (CTD format).
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • The ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.

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