Regulatory Affairs _ US Market

4 days ago

Hyderabad, Telangana, India BVR People Consulting Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Greetings

We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.

Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes.

Key Responsibilities:

  • Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions.
  • Responsible for filing supplements: CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates.
  • Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines.
  • Strong interpretation of FDA queries and drafting of high-quality responses.
  • Review and preparation of CMC sections (Module 2 & 3).
  • Evaluation and interpretation of post-approval changes; preparation of related dossiers.
  • Review of BMRs, specifications (drug product, drug substance, excipients), stability protocols.
  • Preparation of Annual Reports/PEPFAR updates.
  • Ensure compliance with high safety, quality, and regulatory standards.

Desired Candidate Profile

  • M. Pharmacy (Pharmaceutics / Regulatory Affairs) with 611 years of relevant experience.
  • In-depth knowledge of USFDA regulatory requirements.
  • Strong expertise in CMC, post-approval changes, and supplements (CBE, CBE-30, PAS).
  • Excellent drafting, reviewing, and query interpretation skills.
  • Exposure to ANDA/NDA lifecycle management.

Interested Candidates Kindly Share your updated cv to

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