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17 hours ago
**Regulatory Affairs Expertise: A Key to Success**
We are seeking a seasoned Regulatory Affairs professional to spearhead CMC regulatory activities for USFDA submissions.
- Develop and execute strategic plans for ANDA preparation, review, and filing.
- Oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
- Collaborate 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.
- Coordinate with manufacturing units to guarantee product and process compliance aligned with regulatory requirements.
- Stay current on evolving USFDA regulations and provide impact assessments and strategic guidance.
**Requirements for Success:**
- 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings.
- Deep 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 manage end-to-end submission lifecycle including post-approval changes and correspondence with USFDA.
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