Senior Regulatory Compliance Specialist

17 hours ago


Erode, Tamil Nadu, India beBeeRegulatory Full time ₹ 5,67,890 - ₹ 12,34,567

**Regulatory Affairs Expertise: A Key to Success**

We are seeking a seasoned Regulatory Affairs professional to spearhead CMC regulatory activities for USFDA submissions.

  • Develop and execute strategic plans for ANDA preparation, review, and filing.
  • Oversee the 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 with manufacturing units to guarantee product and process compliance aligned with regulatory requirements.
  • Stay current on evolving USFDA regulations and provide impact assessments and strategic guidance.

**Requirements for Success:**

  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings.
  • Deep 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 manage end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.


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