Global Regulatory CMC Lead for Small Molecule NDA

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 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...

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...

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 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...

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...

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 is seeking a Senior CMC Regulatory Consultant to lead the CMC regulatory strategy for a late-phase small molecule asset (MAA under preparation) and to manage the CMC Dossier with support from the regulatory CMC writing team.You will collaborate with cross-functional teams and global affiliates to ensure robust regulatory strategies, submission...

We are a human‑scale, international, and independent pharmaceutical group governed by a Foundation. Our unique model makes us proud and, more importantly, enables us to fully serve our mission: "Committed to therapeutic progress for the benefit of patients.". As a global leader in cardiology, we aim to become a focused and innovative player in oncology by...