
Senior Regulatory Affairs Specialist
2 weeks ago
- Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.
- Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
- Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
- Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
- Coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
- Stay updated on evolving USFDA regulations and provide impact assessment and strategic guidance.
Key Requirements:
- 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.
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