Director, Global Regulatory Lead - Oncology

Takeda

Boston, MA, US
Base: $177,000.00 - $278,080.00; bonus/equity: not...
Hybrid
Global regulatory strategy
Major regulatory submissions
Us fda submissions and approvals
Set global regulatory strategy and lead major submissions for high-impact oncology programs

Job Summary

  • Set global regulatory strategy and lead major submissions for high-impact oncology programs.
  • Accountable for all US FDA submissions and approvals of project(s) of responsibility.
  • Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

Matching Summary

Set global regulatory strategy and lead major submissions for high-impact oncology programs.

Salary

Base: $177,000.00 - $278,080.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation

Skills & Requirements

Must-have

  • Global regulatory strategy
  • Major regulatory submissions
  • US FDA submissions and approvals
  • Drug development process
  • Oncology programs

Nice-to-have

  • EU, Canada, ROW knowledge
  • Due diligence assessment
  • Health Technology Assessment bodies
  • Patient support programs

Key Requirements

  • Bachelor’s Degree required
  • Minimum of 8 years pharmaceutical industry experience
  • Knowledge of FDA is a must
  • Experience managing major regulatory filing(s)

Work Rights

Not specified

Tailored Resume

Cover Letter