Job Description
**Job Description**
The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products.
The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Control organization (GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health (GHH) to ensure these programs are compliant and available to patients in markets as needed.
Role reports to Associate Vice President Regulatory ...
The Executive Director, Chemistry, Manufacturing, Control for Biologics (Biologics-CMC) is accountable for managing a team of CMC professionals and ensuring rigor in CMC regulatory strategy as well as delivery of high quality CMC submissions for late phase new modality biologics products.
The Executive Director, as a Senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Control organization (GRACS CMC), will also manage significant projects as an extension of the overall GRACS CMC Leadership Team. This lead plays a critical role in driving alignment and execution globally across Regulatory CMC (Chemistry, Manufacturing & Controls), GRACS (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global Human Health (GHH) to ensure these programs are compliant and available to patients in markets as needed.
Role reports to Associate Vice President Regulatory ...