Global Head, Regulatory Science & Real-World Evidence

BioSpace; Morristown (NJ); On-site; USD 200,000 - 300,000; Full time

Job summary

Sanofi in Morristown, NJ, seeks a Global Head of Regulatory Science Model-Enabled Development, Real World Evidence and Novel Endpoints to lead a center of excellence for regulatory strategies. You'll drive model-informed drug development and regulatory validation across development stages, guiding cross-functional teams and partnering with TMU, Clinical Development, Biostatistics, and more.

You will influence regulatory thinking, manage complex submissions, and shape the strategy for novel

Qualifications

• 10–15 years in regulatory affairs with global authority interactions.
• Direct experience with MIDD, pharmacometrics, modeling and simulation.
• Proven track record in regulatory submissions involving advanced modeling or endpoints.

Responsibilities

• Provide leadership and strategic vision, design teams, recruit and develop talent.
• Develop regulatory strategy frameworks for model-enabled development across all phases.
• Lead regulatory validation projects (e.g., endpoints) from concept to approval.
• Engage with global agencies (FDA/EMA) and align with R&D partners on strategies.
• Drive knowledge management and cross-functional collaboration for regulatory science.

Skills

Regulatory affairs leadership

Model-Informed Drug Development (MIDD)

Pharmacometrics

Modeling & simulation

Novel endpoint development

Regulatory strategy

Education

Bachelor's degree

Advanced degree in quantitative science

Job description

Sanofi in Morristown, NJ, seeks a Global Head of Regulatory Science Model-Enabled Development, Real World Evidence and Novel Endpoints to lead a center of excellence for regulatory strategies. You'll drive model-informed drug development and regulatory validation across development stages, guiding cross-functional teams and partnering with TMU, Clinical Development, Biostatistics, and more.

You will influence regulatory thinking, manage complex submissions, and shape the strategy for novel