Senior Regulatory CMC Consultant

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