Senior Director, Global Regulatory Lead – Oncology

Takeda UK

Boston, MA, US
Base: $212,000.00 - $333,190.00; bonus/equity: not...
Hybrid
Global regulatory strategy
Late-stage oncology projects
Us fda submissions and approvals
Lead a top-priority oncology program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies

Job Summary

  • Lead a top-priority oncology program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies.
  • Set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs.
  • Accountable for US FDA submissions and approvals of project(s) of responsibility, and may serve as the primary FDA point of contact.

Matching Summary

Lead a top-priority oncology program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies.

Salary

Base: $212,000.00 - $333,190.00; 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
  • Late-stage oncology projects
  • US FDA submissions and approvals
  • Cross-functional team leadership
  • Regulatory affairs expertise

Nice-to-have

  • Innovative access strategies
  • Due diligence for licensing
  • Coaching and mentoring

Key Requirements

  • BSc/BA Degree in scientific discipline
  • 12+ years pharmaceutical industry experience
  • 10 years regulatory experience
  • Experience with late-stage regulatory submissions
  • Knowledge of FDA and EU regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter