Global Regulatory CMC Lead, Small Molecules

Excelya is seeking a consultant to lead the global Regulatory CMC strategy for a small molecule, focusing on Module 3 preparation, Marketing Authorization Applications, and global health authority interactions. The role requires strong knowledge of FDA/EMA/ICH and proven experience in Module 3 submissions, in a cross-functional, international setting.

The successful candidate will manage regulatory risks, work with cross-functional teams, and ensure submission content is scientifically robust