Associate Director, Global Regulatory Affairs CMC

The Associate Director, Global Regulatory Affairs CMC role at Takeda involves developing and leading regulatory CMC strategies for assigned products, with a focus on global regulatory compliance and success. This role requires a strong understanding of global RA CMC regulations and guidelines, as well as excellent analytical and communication skills. The ideal candidate will have 10+ years of biopharmaceutical/device industry experience, with 5+ years of pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. This is a hybrid role with Takeda's Hybrid and Remote Work policy.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred
• 10+ years of overall biopharmaceutical/device industry experience
• 5+ years pharmaceutical Regulatory CMC or Device experience
• Experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA

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
• Sick time
• Paid vacation