Senior Global Regulatory CMC Lead

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...

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.The...

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...

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.Our client is...

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...

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...

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...

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Global Regulatory Submission Manager Consultant to join our dynamic team. This role is responsible for leading and coordinating global regulatory submission activities across the entire product lifecycle, from First-in-Human (FIH) development through...