Global Head, Regulatory Science — Model-enabled Development, Real World Evidence And Novel Endpoints

Sanofi

Morristown, NJ, USA
Base: $266,250.00 - $384,583.33; bonus/equity: not...
Not specified
10-15 years regulatory affairs experience
Model-informed drug development midd expertise
Real world evidence strategy development
Sanofi is seeking a Global Head for Regulatory Science focusing on model-enabled development, real-world evidence, and novel endpoints. This leadership role requires extensive regulatory affairs experience, particularly in model-informed drug development, and emphasizes collaboration with various R&D functions to drive innovative regulatory strategies

Job Summary

  • This role serves as a specialized center of excellence driving innovation in regulatory science through advanced model-informed approaches and real-world evidence.
  • The position requires leading strategic negotiations with worldwide regulatory agencies including the FDA and EMA on emerging model development topics.
  • Sanofi offers a competitive salary range, comprehensive health benefits, and at least 14 weeks of gender-neutral parental leave for this global leadership role.

Matching Summary

Match Score: 85

Sanofi is seeking a Global Head for Regulatory Science focusing on model-enabled development, real-world evidence, and novel endpoints. This leadership role requires extensive regulatory affairs experience, particularly in model-informed drug development, and emphasizes collaboration with various R&D functions to drive innovative regulatory strategies.

Salary

Base: $266,250.00 - $384,583.33; Bonus/Equity: Not specified; Benefits: High-quality healthcare, wellness programs, 14+ weeks parental leave

Skills & Requirements

Must-have

  • 10-15 years regulatory affairs experience
  • Model-Informed Drug Development MIDD expertise
  • Real World Evidence strategy development
  • Novel endpoint validation leadership
  • FDA and EMA agency engagement
  • Team building and organizational design

Nice-to-have

  • Experience with Regulatory Health Authority
  • PhD in quantitative science fields
  • Participation in industry consortia
  • AI-powered research environment
  • Cross-functional matrix collaboration

Key Requirements

  • Minimum 10-15 years regulatory affairs experience
  • Bachelor's degree required; Advanced degree highly desirable
  • Proven track record in regulatory submissions with modeling
  • Leadership experience in building specialized teams

Work Rights

Not specified

Tailored Resume

Cover Letter