Director, Global Regulatory Lead - Oncology

Takeda

Boston, MA, USA
Base: $177,000.00 - $278,080.00; bonus/equity: sho...
Hybrid
8 years pharmaceutical industry experience
Solid knowledge of fda regulatory requirements
Experience managing major nda/bla/maa submissions
This role involves setting global regulatory strategy and leading major submissions for high-impact oncology programs at Takeda

Job Summary

  • This role involves setting global regulatory strategy and leading major submissions for high-impact oncology programs at Takeda.
  • The successful candidate will serve as the primary FDA contact and ensure all US submissions are executed on time with high quality.
  • Takeda offers a competitive salary range, comprehensive benefits including medical and dental insurance, and up to 120 hours of paid vacation.

Matching Summary

This role involves setting global regulatory strategy and leading major submissions for high-impact oncology programs at Takeda.

Salary

Base: $177,000.00 - $278,080.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k) match, disability, life insurance, tuition reimbursement, sick time, and vacation

Skills & Requirements

Must-have

  • 8 years pharmaceutical industry experience
  • Solid knowledge of FDA regulatory requirements
  • Experience managing major NDA/BLA/MAA submissions

Nice-to-have

  • Knowledge of EU, Canada, ROW regulations
  • Strong negotiation and communication skills
  • Ability to lead cross-functional task forces

Key Requirements

  • Bachelor's degree required; advanced scientific degree preferred
  • Minimum 8 years of pharmaceutical industry experience
  • Must have solid working knowledge of drug development process

Work Rights

Not specified

Tailored Resume

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