Global Head, Regulatory Science – Model-Enabled Development, Real World Evidence, Novel Endpoints
Sanofi
full-time
Posted on:
Location Type: Office
Location: Morristown • Massachusetts • New Jersey • United States
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Salary
💰 $266,250 - $384,583 per year
Job Level
About the role
- Provide Leadership and Strategic Vision for organizational design and resource allocation
- Develops and Implements Innovative Regulatory Strategies across all development phases
- Oversees strategic negotiations and engagement with worldwide Regulatory Agencies
- Drives Knowledge Management and Capability Building for specialized regulatory expertise
- Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration
Requirements
- Minimum 10-15 years of regulatory affairs experience
- Direct experience with Model-Informed Drug Development (MIDD)
- Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints
- Demonstrated leadership experience in building and developing specialized teams
- Strong knowledge of Model-enabled frameworks and regulatory pathways for novel endpoint validation
- Bachelor's degree required. Advanced degree in a quantitative science field highly desirable.
Benefits
- Health insurance
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsModel-Informed Drug Developmentregulatory submissionsadvanced modeling approachesinnovative endpointsModel-enabled frameworksregulatory pathwaysendpoint validation
Soft Skills
leadershipstrategic visioncollaborationknowledge managementcapability building
Certifications
Bachelor's degreeadvanced degree in quantitative science