Director, Global Regulatory Affairs Cmc

Takeda

Boston, MA, US
Base: $177,000.00 - $278,080.00; bonus/equity: sho...
Hybrid
Global regulatory affairs cmc strategy
Leading major registrational submissions
Nda bla maa preparation experience
This role within Takeda's Global Regulatory Affairs organization focuses on unlocking innovation to deliver transformative therapies worldwide

Job Summary

  • This role within Takeda's Global Regulatory Affairs organization focuses on unlocking innovation to deliver transformative therapies worldwide.
  • The successful candidate will independently develop regulatory CMC strategies and lead the execution of investigational, registration, and post-approval plans.
  • Takeda offers a hybrid work environment with competitive compensation ranging from $177,000 to $278,080 plus comprehensive benefits.

Matching Summary

This role within Takeda's Global Regulatory Affairs organization focuses on unlocking innovation to deliver transformative therapies worldwide.

Salary

Base: $177,000.00 - $278,080.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), paid time off, tuition reimbursement

Skills & Requirements

Must-have

  • Global Regulatory Affairs CMC strategy
  • Leading major registrational submissions
  • NDA BLA MAA preparation experience
  • Health Authority interaction skills
  • 10+ years biopharmaceutical industry experience

Nice-to-have

  • Mentoring GRA CMC team members
  • Cross-functional collaboration skills
  • Inclusive culture promotion
  • Strategic risk assessment abilities

Key Requirements

  • BS/BA Degree in Scientific Discipline required
  • Advanced Degree (MS, PhD) required
  • 10+ years overall biopharma/device experience
  • 8+ years pharmaceutical Regulatory CMC experience
  • Proven leadership in NDA/BLA/MAA submissions

Work Rights

Not specified

Tailored Resume

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