Global Regulatory CMC Lead - Module 3 & NDA Strategy

Excelya is seeking a seasoned Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and regulatory submission readiness. The role involves interactions with FDA, EMA and other health authorities, ensuring robust, compliant submissions across international markets.

We value strong regulatory strategy, cross-functional collaboration, and the ability to navigate complex submissions with scientific rigor.