Executive Director, Global Regulatory Affairs CMC Early Development

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. 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.

Requirements

• 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 related CMC regulatory experience), including leadership for small molecule and/or biologic products in early development
• Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations (FDA, EMA, MHRA, PMDA); experience across additional regions a plus.
• Ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• Up to 120 hours of paid vacation