Global Head, Regulatory Science - Model-Enabled Dev & RWE

Mass Digital Health; Cambridge (MA); On-site; USD 266,000 - 385,000; Full time

Job summary

Sanofi is seeking a Global Head, Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints across global regulatory programs. You will shape regulatory strategy, guide validation projects, and partner with R&D to integrate regulatory considerations early in development.

The role requires extensive experience in regulatory science, leadership, and strong collaboration with agencies and cross-functional teams to accelerate medicines development.

Qualifications

• Requires 10–15 years in regulatory affairs with progression and interactions with health authorities.
• Experience with MIDD, pharmacometrics, modeling/simulation, or novel endpoint development.
• Leadership experience in building specialized teams and centers of excellence.

Responsibilities

• Provide leadership and strategic vision for model-enabled regulatory strategies.
• Oversee development of regulatory strategy frameworks across development phases.
• Lead regulatory validation projects (e.g., endpoint validation) from concept to approval.
• Engage with global regulatory agencies (FDA, EMA) and health authorities.
• Drive knowledge management and capability building within the team.
• Ensure excellence in regulatory submissions and cross-functional collaboration.

Skills

Regulatory affairs

Model-Informed Drug Development

Pharmacometrics

Modeling & Simulation

Leadership

Education

Bachelor's degree in quantitative science

Advanced degree (Masters, Pharm D, PhD) in a quantitative science

Job description

Sanofi is seeking a Global Head, Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints across global regulatory programs. You will shape regulatory strategy, guide validation projects, and partner with R&D to integrate regulatory considerations early in development.

The role requires extensive experience in regulatory science, leadership, and strong collaboration with agencies and cross-functional teams to accelerate medicines development.