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Partners with cross-functional leaders (CMC, Regulatory, Development, Clinical, Nonclinical, Quality, Safety, Manufacturing, Supply Chain, and Digital/Data) to align CMC development plans, to regional regulatory expectations and program timelines. Establish best practices and a strong regulatory com
Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development, analytical, formulation, drug substance/drug product, device/combination where applicable, quality, clinical, and manufacturing) to ensure consistent, high-quality exec
As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivot
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC inve
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
Executive Director, Global Regulatory Affairs CMC Early Development you will p rovide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.
If Bike: Have a government-issued ID.