Senior Director, Global Regulatory Strategy, Oncology

Moderna Inc

Base: $196,700.00 - $353,400.00; bonus/equity: eli...
12+ years pharmaceutical industry experience
8+ years regulatory strategy in oncology
Experience with fda ema pmda interactions
This role requires a seasoned leader to shape regulatory pathways for novel, first-in-class oncology therapeutics from early development through commercialization

Job Summary

  • This role requires a seasoned leader to shape regulatory pathways for novel, first-in-class oncology therapeutics from early development through commercialization.
  • The successful candidate will drive regulatory submissions and lead high-stakes negotiations with health authorities like the FDA, EMA, and PMDA.
  • Moderna offers best-in-class healthcare coverage, family planning benefits, and a holistic approach to well-being including fitness and mental health support.

Matching Summary

Match Score: 85

This role requires a seasoned leader to shape regulatory pathways for novel, first-in-class oncology therapeutics from early development through commercialization.

Salary

Base: $196,700.00 - $353,400.00; Bonus/Equity: Eligible for annual discretionary bonus and equity award; Benefits: Best-in-class healthcare, paid time off, and savings opportunities

Skills & Requirements

Must-have

  • 12+ years pharmaceutical industry experience
  • 8+ years regulatory strategy in oncology
  • Experience with FDA EMA PMDA interactions
  • Expertise in CTD format regulatory filings
  • Track record securing product approvals

Nice-to-have

  • Graduate degree in scientific discipline
  • Delivery of major NDA BLA MAA applications
  • Executive presence and strategic leadership
  • Ability to challenge convention and act with urgency

Key Requirements

  • BA/BS degree in scientific or engineering discipline
  • 12+ years total pharmaceutical industry experience
  • 8+ years specific experience in regulatory strategy
  • Direct experience leading regulatory authority meetings
  • US person status required due to export controls

Work Rights

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

Tailored Resume

Cover Letter