Principal Regulatory Compliance Specialist

9 hours ago


Thrissur, Kerala, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Regulatory Affairs Specialist

The ideal candidate will be responsible for leading and managing CMC regulatory activities, including USFDA submissions.

Key Responsibilities:

  • Compile and submit Annual Reports, amendments, and deficiency responses to ensure compliance with regulatory requirements.
  • Interface with cross-functional teams to gather required documentation and data for submissions.
  • 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 aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide strategic guidance to the team.

Requirements:

  • A minimum of 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 including post-approval changes and correspondence with USFDA.

Why this role matters:

This position plays a critical role in ensuring our company's products meet regulatory standards, which ultimately affects public health and safety.



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