Senior Regulatory CMC Project lead

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 Regulatory CMC.

Main Responsibilities:
- Leading the global CMC Regulatory strategy for one small molecule asset (late phase; MAA under preparation)
- Defining, developing, owning and executing the global CMC Regulatory strategy whilst maximizing the regulatory outcomes for this asset.
- Ensure that CMC Regulatory strategies are an enabler to potential accelerated product development pathways to ensure speed up product delivery to patients.
- Effective project management skills to ensure high quality and timely delivery of regulatory documents.
- Leading the CMC strategy for all agency interactions for the allocated asset (including the preparation of the BB).
- Represent CMC Regulatory on the asset cross-functional technical, regulatory and governance meetings as needed.

- Provide CMC Regulatory support to the Reg CMC technical writing team in relation to the respective country requirements
- Liaise with the Local Affiliate of the respective countries to develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
- Generate gap analysis and risk management support for each submission in the core markets as needed
- Compile regulatory documents in support of each submission in the core markets on time and in line with country requirements