Regulatory Affairs Professional

2 days ago


Varanasi, Uttar Pradesh, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title:

Senior Regulatory Affairs Specialist

About This Role:
  • The successful candidate will lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
  • This includes overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.
  • The individual will interface with cross-functional teams to gather required documentation and data.
  • They will review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Additionally, they will coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • The role requires staying updated on evolving USFDA regulations and providing impact assessments and strategic guidance.
Key Responsibilities:
  • Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.
  • Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Interface with cross-functional teams including Quality Assurance, Production, and R&D 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 ensure product and process compliance aligned with regulatory requirements.
  • Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.
Requirements:
  • 7–10 years of hands-on 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, 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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