Senior Regulatory Compliance Expert

5 days ago


Salem, Tamil Nadu, India beBeeRegulatoryAffairs Full time ₹ 36,00,000 - ₹ 45,00,000
Job Description:

As a Senior Regulatory Affairs Specialist, you will be responsible for leading and managing CMC regulatory activities for USFDA submissions. This includes preparing, reviewing, and filing ANDA documents, as well as overseeing the compilation and submission of Annual Reports, amendments, and deficiency responses.

Key Responsibilities:
  • Manage and execute CMC regulatory strategies to ensure compliance with USFDA regulations.
  • Oversee the development and maintenance of regulatory documentation, including Batch Manufacturing Records (BMR) and process validation documents.
  • Collaborate with cross-functional teams, including Quality Assurance, Production, and R&D, to gather required documentation and data.
  • Review and ensure compliance of product and process data with regulatory requirements.
  • Stay up-to-date on evolving USFDA regulations and provide impact assessments and strategic guidance.
Required Skills and Qualifications:
  • 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.
Benefits:

This role offers a unique opportunity to work in a dynamic and challenging environment, with opportunities for growth and development.

Others:

The ideal candidate will have excellent communication and project management skills, with the ability to work effectively in a team environment.



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