Regulatory Affairs Expert

2 weeks ago


Tiruchi, Tamil Nadu, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000
Regulatory Affairs Professional

The ideal candidate will possess a strong background in regulatory affairs, with a focus on chemical, manufacturing, and controls (CMC) aspects.

Key Responsibilities:

  • Oversee the compilation and submission of 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 guarantee product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving regulations and provide impact assessments and strategic guidance to stakeholders.

Required Skills and Qualifications:

  • A minimum of 7-10 years of hands-on experience in regulatory affairs – CMC with USFDA filings, particularly 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, BMR review, and interacting with production/plant teams.
  • Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.


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