Senior Manager, CMC Regulatory Affairs
Bachelor's in a scientific discipline required; 8 years in reputed company with 6+ years in regulatory. Experience with CMC submissions (IND/CTA/NDA/MAA/ANDA), FDA/EMA interactions, GxP, change control, and regulatory document management. Travel ~5–10%.
Key Responsibilities
- developing reputed company
- preparing dossiers
- supporting submissions
Job Details
- Category: Research and Development (R&D)
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Languages: English
Benefits
- Retirement plan
About reputed company
Develops innovative lipid-lowering therapies to improve cardiovascular health. — Industry: Research and Development
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