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Senior Regulatory Compliance Officer

2 weeks ago

India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000

Regulatory Affairs Specialist Role

This position focuses on managing regulatory activities for pharmaceutical products in the United States. Key responsibilities include preparing and reviewing documentation, ensuring compliance with FDA guidelines, and interacting with cross-functional teams.

  • Lead and manage regulatory activities, including ANDA preparation, review, and filing.
  • Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Interface with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.

To succeed in this role, candidates should have a strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products. They should also be able to prepare and review technical documents, handle end-to-end submission lifecycle, and demonstrate experience in quality systems, BMR review, and production team interactions.

Requirements:

  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings.
  • Strong analytical skills, attention to detail, and ability to prioritize tasks effectively.
  • Excellent communication and interpersonal skills for collaborating with cross-functional teams.
  • Ability to adapt to changing regulations and maintain up-to-date knowledge of industry developments.