Executive Director, Global Regulatory Affairs CMC Early Development

Role: Executive Director, Global Regulatory Affairs CMC Early Development, providing strategic leadership for global CMC regulatory strategies and submissions for small molecules and biologics from first-in-human to pre-pivotal phases. Responsibilities: oversee global CMC teams, develop fit-for-phase regulatory approaches, lead key health authority interactions, and advance innovative digital and in silico methodologies to streamline development and submissions. Collaborate with cross-functional teams (CMC, Regulatory, Development, Quality, Manufacturing, Digital) to align development plans, mitigate risks, and ensure inspection readiness. Represent Takeda at senior levels and with global regulators including FDA, EMA, PMDA. Requirements: MS, PhD, or PharmD in a scientific/engineering discipline; 20+ years’ experience in global CMC regulatory affairs, including leadership of early development programs for small molecules and biologics; deep knowledge of ICH guidelines, regional regulatory expectations, and experience managing global regulatory submissions and negotiations. Preferred: expertise in digital and modeling approaches, and experience across multiple regions. High-value specifics include biologics and small molecules, Phase 1-2 development, and emphasis on innovation in digital CMC strategies. Work setup: hybrid Boston; relocation support may apply.