Global Head, Regulatory Science – Model-Enabled Development

Sanofi; Morristown (NJ); On-site; USD 250,000 - 320,000; Full time

Benefits offered by this job

Health and wellbeing benefits

14 weeks parental leave

International travel opportunities

Job summary

Sanofi in Morristown, NJ, is seeking a Global Head of Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints within the Regulatory Science center of excellence. You will shape strategic regulatory frameworks and drive cross-functional collaboration with TMU, Clinical Development, Biostatistics, and R&D partners to accelerate informed decision-making.

The role requires 10–15 years in regulatory affairs with deep expertise in MIDD, pharmacometrics, and

Qualifications

• Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions.
• Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development is highly desirable.
• Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints.
• Leadership experience in building and developing specialized teams, including organizational design, people leadership, and succession planning.

Responsibilities

• Provides Leadership and Strategic Vision: Accountable for organizational design, people development, resource allocation, and metrics for the expert unit; develops center of excellence in model-enabled regulatory strategies and submissions.
• Develops and Implements Innovative Regulatory Strategies: Oversees regulatory strategy frameworks for Model-Enabled Drug Development across all development phases; coordinates with GRLs and R&D partners.
• Leads Strategic Engagement with Regulatory Agencies: Oversees engagement with FDA, EMA and other agencies; develops health authority engagement plans and represents Sanofi at agency meetings.
• Drives Knowledge Management and Capability Building: Builds expertise in model-enabled development and real-world evidence; creates SOPs, training materials, and knowledge platforms.
• Ensures Excellence in Regulatory Submissions and Cross-Functional Collaboration: Oversees preparation, review, and approval of submissions; ensures cross-functional collaboration and governance.

Skills

Regulatory affairs

Model-Informed Drug Development (MIDD)

Pharmacometrics

Modeling and simulation

Novel endpoint development

Leadership

Strategic thinking

Communication skills

Education

Bachelor's degree in a quantitative science

Advanced degree in Pharmacometrics/Biostatistics/Pharmacology or related field

Job description

Sanofi in Morristown, NJ, is seeking a Global Head of Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints within the Regulatory Science center of excellence. You will shape strategic regulatory frameworks and drive cross-functional collaboration with TMU, Clinical Development, Biostatistics, and R&D partners to accelerate informed decision-making.

The role requires 10–15 years in regulatory affairs with deep expertise in MIDD, pharmacometrics, and