Regulatory Compliance Manager

2 days ago


Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Regulatory Affairs Specialist

About the Role:

We are seeking a Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for leading and managing regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.

Key Responsibilities:

  • Manage regulatory activities for USFDA submissions, including 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.
  • Ensure compliance of batch manufacturing records, process validation documents, and site-related data.
  • Coordinate with manufacturing units to ensure product and process compliance with regulatory requirements.
  • Stay up-to-date on evolving USFDA regulations and provide strategic guidance.

Required Skills and Qualifications:

  • 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 and reviewing technical documents: Module 2 & 3 (CTD format).
  • Exposure to quality systems and interacting with production/plant teams.
  • Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.

What We Offer:

Our company offers a dynamic work environment, competitive salary, and opportunities for professional growth and development.



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