Senior Manager, Global Regulatory Affairs CMC

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
• 6+ years 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
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams
• Analyze issues with attention to detail
• Ability to assess alternative approaches
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines
• Excellent written and oral communication skills required

Benefits

• Short-term and/or long-term incentives
• 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