Global Regulatory CMC Lead

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...

Excelya Group is seeking a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. You will drive regulatory strategy, lead Module 3 CMC content, and coordinate with global health authorities to support MAAs, BLAs, and lifecycle management.The role requires...

Excelya is seeking a Senior Regulatory Consultant to deliver strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate (ADC) biologics program. The role requires steering global CMC activities for MAA/BLA submissions, with an emphasis on strategy and matrix-management leadership.The consultant will interact with global health...

Excelya in Île-de-France is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule programs, with emphasis on Module 3 preparation and MAAs. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure submission readiness.The role requires solid Regulatory CMC experience, strong FDA/EMA/ICH...

About the Job At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team. This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to...

DescriptionAbout the JobAt Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to...

Excelya Group in France seeks a Senior CMC Regulatory Consultant to lead the global CMC regulatory strategy for a late-phase small molecule asset, including MAA preparation, with cross-functional collaboration to ensure submission excellence.You will coordinate with affiliate teams, manage the CMC dossier with the writing team, and guide regulatory input...

DescriptionJoin 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.Our...

Excelya is seeking a Global Regulatory Submission Manager Consultant to lead and coordinate global regulatory submission activities across the product lifecycle, including FDA, EU, China, and Japan. You will drive planning, dossier preparation, and interactions with external vendors in a fast-paced, cross-functional environment.Based in Saclay, France, the...