Executive Director, Global Regulatory Affairs CMC Early Development

Executive Director, Global Regulatory Affairs CMC Early Development Join us as Executive Director, Global Regulatory Affairs CMC Early Development (GRA CMC ED). You will provide strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase2 development. You will champion fit‑for‑phase CMC approaches that accelerate development while ensuring product quality, patient safety and inspection readiness. A key element of this role is advancing the use of in‑silico approaches and digital innovation in CMC development (modeling/simulation, predictive tools, data and knowledge management, digital CMC dossiers) to strengthen scientific justifications, enable right‑first‑time submissions and improve speed & decision‑making. Objectives and Purpose 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 from FIH to pre‑pivotal development. Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions 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 & digital approaches to product and process development across major regions. Responsibilities Lead and develop a team of regulatory leaders and subject‑matter experts, overseeing global CMC regulatory strategy and key submissions/health‑authority interactions for an assigned portfolio from FIH to pre‑pivotal. Partner with cross‑functional leaders to align CMC development plans with regional regulatory expectations and program timelines. Ensure governance teams and key stakeholders are apprised of CMC developments impacting regulatory success. Anticipate risks and drive mitigation plans consistent with quality risk‑management principles. Represent Global Regulatory Affairs CMC in senior‑level governance and in interactions with global health authorities (FDA, EMA, MHRA, PMDA, etc.). Ensure global CMC content quality and compliance for early development submissions and lifecycle changes through Phase2. Lead departmental and cross‑functional initiatives to advance fit‑for‑phase and platform approaches in early development CMC. Provide CMC regulatory strategy leadership for business development and due diligence. Monitor and anticipate global regulatory trends impacting early development CMC. Champion use of in‑silico approaches and digital capabilities in CMC. Demonstrate Takeda leadership behaviors. Dimensions and Aspects Technical/Functional Expertise: Comprehensive understanding of global CMC regulatory requirements and expectations through Phase2. Leadership: Ability to work across functions, regions, cultures; inspire, motivate, drive results; excellent communicator; team player; ability to distil complex issues. Decision‑Making and Autonomy: Provide input to highly complex decisions; accountable for decision making; incorporate feedback; implement strategy. Interaction: Effectively navigate external and internal environments; build broad networks; represent function in negotiations. Innovation: Forward‑thinking, influence, implement organizational change and continuous innovation; challenge status quo. Complexity: Work in a global ecosystem with high degree of complexity; deep expertise; see broader enterprise perspective. Education, Behavioral Competencies and Skills Advanced degree in a scientific or engineering discipline (MS, PhD, PharmD). 20+ years of industry experience with significant experience in Global Regulatory Affairs CMC, including leadership for small molecule and/or biologic products in early development. Significant experience leading, reviewing, authoring, or managing CMC content for global regulatory submissions and responses. Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements. Understanding of ICH guidance and regional expectations. Experience integrating in‑silico modeling/simulation and digital data strategies into CMC development and regulatory justifications. Strong oral and written communication, negotiation skills, integrity, adaptability. Strategic thinking and increasing independence; proactive identification of regulatory issues and mitigation strategies. Ability to work well with others and within global teams; bring teams together for common objectives. Compensation and Benefits Location: Boston, MA, U.S. Base Salary Range: $238,000.00 – $374,000.00. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well‑being benefits, and sick time up to 80 hours per year. New hires are eligible to accrue up to 120 hours of paid vacation. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr