Senior Regulatory CMC (Small Molecule)
Excelya · Saclay, Île-de-France
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- Company
- Excelya
- Location
- Saclay, Île-de-France
- Employment type
- Full-time
- Posted
- September 23, 2026
About this job
The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness Missions Lead the global Regulatory CMC strategy and support Marketing Authorization Applications Lead/review Module 3 preparation and submission activities Support interactions with FDA, EMA and other Health Authorities, including responses to questions Identify regulatory risks and define appropriate mitigation strategies Operate effectively within a global and cross-functional matrix environment Ensure alignment of CMC regulatory strategies with overall development and commercialization objectives…
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Salaries in France
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