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

Sanofi EU; Cambridge (MA); On-site; USD 250,000 - 360,000; Full time

Benefits offered by this job

Health benefits

Wellness programs

Parental leave (14 weeks)

Job summary

Sanofi invites a Global Head of Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints across development stages. You will shape regulatory strategy and agency engagement.

This executive oversees a center of excellence, partnering with Translational Medicine, Clinical Development, Biostatistics, and external stakeholders to ensure early regulatory integration of modeling, endpoints, and evidence.

Qualifications

• 10–15 years in regulatory affairs with demonstrated progression.
• Direct experience with Model-Informed Drug Development (MIDD) and novel endpoints.
• Proven ability to lead specialized teams and drive cross-functional collaboration.
• Bachelor’s degree required; advanced degree in quantitative sciences preferred.

Responsibilities

• Provides Leadership and Strategic Vision for the expert unit.
• Develops and implements regulatory strategy frameworks across development phases.
• Leads strategic engagement with worldwide regulatory agencies including FDA/EMA.
• Drives knowledge management and capability building within GRA.
• Ensures excellence in regulatory submissions and cross-functional collaboration.

Skills

Regulatory leadership

MIDD expertise

Strategic vision

Cross-functional leadership

Regulatory strategy

Stakeholder management

Regulatory submissions

Communication skills

Project governance

Regulatory health authority liaison

Education

Bachelor's degree

Advanced quantitative degree

Tools

Modeling tools

Job description

Sanofi invites a Global Head of Regulatory Science to lead model-enabled development, real-world evidence, and novel endpoints across development stages. You will shape regulatory strategy and agency engagement.

This executive oversees a center of excellence, partnering with Translational Medicine, Clinical Development, Biostatistics, and external stakeholders to ensure early regulatory integration of modeling, endpoints, and evidence.