Senior Regulatory Compliance Expert

1 day ago

Pune, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Overview:

We are seeking an experienced Regulatory Compliance Specialist to join our team. This role will be responsible for managing CMC regulatory activities, including preparing and submitting documentation to the USFDA.

Main Responsibilities:

  • Lead and coordinate CMC regulatory submissions, ensuring compliance with USFDA regulations and guidelines.
  • 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 product and process compliance with manufacturing units and regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide strategic guidance.

Key Requirements:

  • 7–10 years of hands-on 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 and correspondence with USFDA.

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