
CMC Regulatory Lead
3 days ago
We are seeking a highly skilled Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities, ensuring compliance with evolving USFDA regulations.
- Lead and Manage CMC Regulatory Activities: Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.
- Interface with Cross-Functional Teams: Gather required documentation and data to ensure accurate submissions.
- Review and Ensure Compliance: Batch Manufacturing Records (BMR), process validation documents, and site-related data must align with regulatory requirements.
- Coordinate with Manufacturing Units: Ensure product and process compliance is maintained according to regulatory guidelines.
To be successful in this role, you will have:
- 7-10 Years of Experience: In Regulatory Affairs - CMC, with a strong understanding of ICH, USFDA guidelines, and regulatory frameworks applicable to generic drug products.
- Technical Document Preparation: Experience in preparing and reviewing technical documents: Module 2 & 3 (CTD format).
- Quality Systems and BMR Review: Familiarity with quality systems and interacting with production/plant teams.
- End-to-End Submission Lifecycle: Ability to handle post-approval changes and correspondence with USFDA.
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