Leads and develops a team of regulatory leaders and subject matter experts, overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products through Phase 2. 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. 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-pivotal development, maximizing global regulatory success and minimizing time to clinical milestones.