Executive Director, Global Regulatory Affairs Cmc Devices And Drug-device Combination Product

Takeda

Boston, MA, US
Base: $238,000.00 - $374,000.00; bonus/equity: not...
Hybrid
Global regulatory strategy
Drug-device combination products
Medical device regulatory
Provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products

Job Summary

  • Provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products.
  • Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions.
  • At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Matching Summary

Provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products.

Salary

Base: $238,000.00 - $374,000.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), PTO

Skills & Requirements

Must-have

  • Global regulatory strategy
  • Drug-device combination products
  • Medical device regulatory
  • Regulatory submissions
  • Regulatory policy shaping
  • Cross-functional leadership

Nice-to-have

  • Transformative therapies
  • Patient-focused company
  • Inclusive, collaborative workplace
  • Innovation encouragement

Key Requirements

  • 20+ years industry experience
  • 10+ years Regulatory Affairs
  • Advanced degree in scientific/engineering discipline
  • Experience leading regulatory submissions
  • Strong knowledge of FDA, EU MDR/IVDR

Work Rights

Not specified

Tailored Resume

Cover Letter