Senior Regulatory Affairs Expert

1 day ago


Agra, Uttar Pradesh, India beBeeRegulatoryAffairs Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Regulatory Affairs Specialist Role Overview

  • Our organization seeks an experienced Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.
  • The successful candidate will oversee compilation and submission of Annual Reports, amendments, and deficiency responses, ensuring compliance with relevant regulations.
  • Key responsibilities include interfacing with cross-functional teams, reviewing documentation, and coordinating with manufacturing units to ensure product compliance.
  • We require a strategic thinker who can stay updated on evolving USFDA regulations and provide impact assessments and guidance.

Key Qualifications:

  • A minimum of 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.
  • Proven ability to prepare and review technical documents in CTD format.
  • Exposure to quality systems, BMR review, and interacting with production/plant teams is essential.
  • Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.


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