Senior Director, Global Regulatory Strategy, Oncology

Moderna

Remote
Base: $196,700.00 - $353,400.00; bonus/equity: eli...
Remote
Global regulatory strategy development
Oncology therapeutic area expertise
Health authority interactions (fda, ema, pmda)
Moderna is seeking a Senior Director of Global Regulatory Strategy for its oncology portfolio, responsible for leading regulatory strategies and submissions, engaging with health authorities, and shaping innovative therapeutic pathways. The ideal candidate will possess extensive regulatory experience, particularly in oncology, and demonstrate strong leadership and strategic thinking skills. This remote position offers competitive compensation and comprehensive benefits

Job Summary

  • Lead global regulatory strategies from early development through commercialization for novel, first-in-class therapeutics.
  • Drive regulatory submissions and lead high-stakes negotiations with health authorities like the FDA, EMA, and PMDA.
  • Build and develop high-performing regulatory teams while anticipating and mitigating regulatory risks.

Matching Summary

Match Score: 85

Moderna is seeking a Senior Director of Global Regulatory Strategy for its oncology portfolio, responsible for leading regulatory strategies and submissions, engaging with health authorities, and shaping innovative therapeutic pathways. The ideal candidate will possess extensive regulatory experience, particularly in oncology, and demonstrate strong leadership and strategic thinking skills. This remote position offers competitive compensation and comprehensive benefits.

Salary

Base: $196,700.00 - $353,400.00; Bonus/Equity: Eligible for annual discretionary bonus, other incentive compensation, or equity award; Benefits: Best-in-class healthcare, well-being resources, family planning, generous PTO

Skills & Requirements

Must-have

  • Global regulatory strategy development
  • Oncology therapeutic area expertise
  • Health authority interactions (FDA, EMA, PMDA)
  • Regulatory submissions (INDs, CTAs, BLAs/MAAs)
  • Novel and first-in-class therapies

Nice-to-have

  • Executive presence
  • Challenging convention
  • Enterprise leadership
  • Strategic impact elevation

Key Requirements

  • BA/BS degree in scientific/engineering
  • 12+ years pharmaceutical industry experience
  • 8+ years regulatory strategy experience (oncology)
  • US and EU regulations knowledge
  • CTD format and content experience
  • Track record of product approvals
  • Employee management and development experience

Work Rights

Must be a US person (citizen, permanent resident, asylee, or refugee)

Tailored Resume

Cover Letter