
CMC Regulatory Affairs Specialist
2 days ago
Regulatory Affairs Specialist Job Description:
- This position is responsible for leading and managing CMC regulatory activities, including preparing, reviewing, and filing USFDA submissions.
- The specialist will oversee the compilation and submission of Annual Reports, amendments, and deficiency responses.
- They will interface with cross-functional teams to gather required documentation and data, ensuring compliance with regulatory requirements.
- The Regulatory Affairs Specialist will review and ensure compliance of Batch Manufacturing Records, process validation documents, and site-related data.
- They will coordinate with manufacturing units to ensure product and process compliance aligned with regulatory requirements.
- Staying up-to-date on evolving USFDA regulations is essential, providing impact assessments and strategic guidance as needed.
Required Skills and Qualifications:
- A minimum of 7-10 years of 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.
- Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
- Exposure to quality systems, BMR review, and interacting with production/plant teams.
- The ability to handle end-to-end submission lifecycle, including post-approval changes and correspondence with USFDA.
About This Opportunity:
This role offers a challenging and rewarding career path for those passionate about regulatory affairs and compliance. If you are a motivated individual with a strong background in CMC regulatory activities, we encourage you to apply.
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