Senior Regulatory Affairs Professional

6 days ago

Anand, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 18,00,000 - ₹ 25,00,000
Regulatory Affairs Expert

Job Summary

We are seeking an experienced Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing. This is an exciting opportunity for a skilled professional to make a significant impact in our organization.

Key Responsibilities:

  • CMC Regulatory Activities: Oversee the development and implementation of CMC regulatory strategies for USFDA submissions, including ANDA preparation, review, and filing.
  • Annual Reports and Deficiency Responses: Ensure timely compilation and submission of Annual Reports, amendments, and deficiency responses.
  • Collaboration with Cross-Functional Teams: Interface with cross-functional teams, including Quality Assurance, Production, and R&D, to gather required documentation and data.
  • Compliance Review: Conduct regular compliance reviews of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
  • Manufacturing Unit Coordination: Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
  • Regulatory Updates: Stay up-to-date on evolving USFDA regulations and provide strategic guidance on their implementation.

Required Skills and Qualifications:

  • Regulatory Affairs Experience: 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
  • ICH and USFDA 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 Us:

We are a dynamic and innovative organization that values expertise, collaboration, and continuous learning. We offer a challenging and rewarding work environment that supports professional growth and development.

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