Executive Director, Global Regulatory Affairs CMC Early Development

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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. 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 execution. Serve as an influential leader internally and externally, shaping early-development CMC regulatory policy, influencing cross-functional decision-making, and advancing adoption of in silico and digital approaches to product and process development across major regions (e.g., US, EU, Japan, China). How you will contribute 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. Ensures governance teams and key stakeholders are apprised of CMC developments impacting regulatory success (e.g., process/formulation changes, analytical readiness, control strategy evolution, comparability considerations, starting material strategy, impurity risk, raw material/supply risk). Anticipates risks and drives mitigation plans consistent with quality risk management principles. Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable, to enable efficient pathways for early development CMC strategies and submissions (e.g., pre-IND/IND/CTA, amendments, Type B/C meetings, scientific advice). Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g., IND/CTA modules, IMPD quality sections, amendments, investigator’s brochure CMC, and responses to health authority questions), partnering with regional leads and technical functions to ensure consistent, inspection-ready documentation. Leads departmental and cross-functional initiatives to advance fit-for-phase and platform approaches in early development CMC, including global harmonization of templates and positions, improved knowledge management, and readiness for accelerated programs (e.g., breakthrough/PRIME/RMAT where applicable). Provides CMC regulatory strategy leadership for business development and due diligence, including assessment of early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility for small molecules and biologics. Monitors and anticipates global regulatory trends impacting early development CMC (e.g., ICH Q12/Q13/Q14/Q2(R2), nitrosamines, elemental impurities, biologics comparability, emerging expectations for modeling/simulation and structured data), translating insights into proactive CMC development and submission strategies. Champions use of in silico approaches and digital capabilities in CMC (e.g., predictive impurity risk assessment, process and formulation modeling, PBPK/biopharmaceutics linkages where relevant, digital data lineage, and content re-use) to improve scientific justification, reduce cycle time, and strengthen global regulatory interactions. Responsible for demonstrating Takeda leadership behaviors. Minimum Requirements/Qualifications: Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD) 20+ years of industry experience with significant experience in Global Regulatory Affairs CMC (or closely re