Senior Regulatory CMC Consultant
Descrizione dell'offerta
Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value. 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 Coordinate with cross-functional teams including CMC, Quality, Manufacturing, Regulatory and Technical teams Ensure consistency, scientific robustness, and regulatory compliance of submission content Provide strategic input regarding regulatory positioning and negotiation approaches Ensure compliance with applicable ICH and global regulatory requirements Requirements Education : Master’s degree or equivalent in Pharmacy, Chemistry, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related scientific discipline. Experience : Solid experience in Regulatory CMC within the pharmaceutical industry, strong expertise in small molecules, proven experience with Module 3 and global Marketing Authorization Applications / NDA submissions. Skills : Strong knowledge of FDA, EMA and ICH requirements. Experience with international markets such as China, Japan,
Dettagli
- Azienda: Excelya
- Sede: Saclay, France
- Tipo di contratto: Tempo pieno
- Fonte: arbeitnow
- Valido fino al: 24 ottobre 2026
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