Global Regulatory CMC Lead for Biologics

Excelya seeks a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership for a global Antibody-Drug Conjugate biologics program. You will lead global CMC strategy for MAA/BLA submissions, lifecycle management, and ensure alignment with development and commercialization objectives.The role requires extensive experience with...

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...

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 Group in Saclay (Île-de-France) is seeking a senior Regulatory CMC consultant to lead the global strategy for small molecule products, focusing on Module 3 preparation and Marketing Authorization Applications. You will coordinate with CMC, Quality, Manufacturing and Regulatory teams to ensure alignment with development and commercialization...

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...

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...

Excelya Group in France seeks a Global Regulatory Submission Manager Consultant to lead and coordinate global regulatory submission activities across the product lifecycle, from First-in-Human (FIH) development through post-approval maintenance and license withdrawal.You will drive submission planning, ensure high-quality dossiers for FDA, EU, China and...

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...

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...