Senior Regulatory Affairs Specialist

18 hours ago

Bikaner, Rajasthan, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 1,50,00,000
Regulatory Affairs Professional

Key Responsibilities:

  • Lead and Manage CMC Regulatory Activities
  • Manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.
  • Oversee Compilation and Submission of Reports
  • Compile and submit Annual Reports, amendments, and deficiency responses.
  • Interface with Cross-Functional Teams
  • Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
  • Review and Ensure Compliance
  • Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Coordinate with Manufacturing Units
  • Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Stay Updated on Evolving Regulations
  • Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Key Requirements:

  • Experience in Regulatory Affairs
  • 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • Strong Understanding of Regulatory Guidelines
  • Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  • Technical Document Preparation
  • Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  • Quality Systems and BMR Review
  • Exposure to quality systems, BMR review, and interacting with production/plant teams.
  • End-to-End Submission Lifecycle
  • Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

About This Role:

This role requires a highly skilled and experienced Regulatory Affairs professional to manage CMC regulatory activities for USFDA submissions. The ideal candidate will have a strong understanding of regulatory requirements and guidelines for generic drug products, as well as experience in preparing and reviewing technical documents.

Responsibilities:

  1. Lead and Manage CMC Regulatory Activities: Manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
  2. Oversee Compilation and Submission of Reports: Compile and submit Annual Reports, amendments, and deficiency responses.
  3. Interface with Cross-Functional Teams: Interface with cross-functional teams, including Quality Assurance, Production, and R&D, to gather required documentation and data.
  4. Review and Ensure Compliance: Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  5. Coordinate with Manufacturing Units: Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  6. Stay Updated on Evolving Regulations: Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.

Requirements:

  1. Experience in Regulatory Affairs: 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  2. Strong Understanding of Regulatory Guidelines: Strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
  3. Technical Document Preparation: Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
  4. Quality Systems and BMR Review: Exposure to quality systems, BMR review, and interacting with production/plant teams.
  5. End-to-End Submission Lifecycle: Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.

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