
Senior Regulatory Affairs Professional
4 days ago
Job Overview:
- A key role within our organization is available for a Senior Regulatory Affairs Specialist who will lead and manage CMC regulatory activities for USFDA submissions.
Key Responsibilities:
- The selected candidate will oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
- They will interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.
- The specialist will review and ensure compliance of Batch Manufacturing Records (BMR), process validation documents, and site-related data.
- They will coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
- Staying updated on evolving USFDA regulations is crucial, and the successful candidate will provide impact assessment and strategic guidance.
Required Skills and Qualifications:
- At least 7–10 years of hands-on experience in Regulatory Affairs – CMC with USFDA filings (especially ANDAs).
- A strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products is essential.
- Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format) is necessary.
- Exposure to quality systems, BMR review, and interacting with production/plant teams is beneficial.
- Ability to handle end-to-end submission lifecycle including post-approval changes and correspondence with USFDA is crucial.
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