About this 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

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.

Global Head, Regulatory Science – Model-Enabled Development, Real World Evidence, Novel Endpoints

Key skills