Senior Regulatory CMC Project lead

About this job

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 post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence. The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the…

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