
Strategic Regulatory Compliance Specialist
5 days ago
Job Summary:
We are seeking a seasoned Regulatory Affairs Specialist to lead and manage CMC regulatory activities for USFDA submissions. The ideal candidate will possess strong expertise in ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
About the Role:
- Manage CMC regulatory activities for USFDA submissions, including ANDA preparation, review, and filing.
- Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
- Interface with cross-functional teams to gather required documentation and data.
- Review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
- C coordinated 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.
Requirements:
- 7-10 years of 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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