
Regulatory Affairs Specialist Lead
1 week ago
Job Summary:
">This role is responsible for leading and managing the compilation, submission, review, and filing of CMC regulatory activities for USFDA submissions.
Key Responsibilities:- ">
- Lead 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 ensure product and process compliance aligned with regulatory requirements.">
- Stay updated on evolving USFDA regulations and provide 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).">
- Ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.
Qualifications:
">The ideal candidate must have strong leadership skills, excellent communication skills, and ability to work effectively with cross-functional teams.
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