Director, Global Regulatory Affairs CMC

The Director, Global Regulatory Affairs CMC will develop and execute regulatory strategies for CMC aspects of global registrational submissions, represent Takeda in Health Authority meetings, and provide guidance to teams on administrative procedural topics.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience.
• Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Excellent written and oral communication skills required.

Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in 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, and well-being benefits, among others.