Supervisor overseeing royalty compliance audits at Armanino India LLP. Leading teams in conducting audits and contract reviews in the music industry.
SA
Onsite Global Head, Regulatory Science – Model-Enabled Development, Real World Evidence, Novel Endpoints
Posted 6 days ago
About the role
- Global Head of Regulatory Science focused on model-enabled development and regulatory science innovation at Sanofi. Collaborating with cross-functional teams to ensure regulatory acceptance in drug development.
Responsibilities
- 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
Requirements
- 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.
Benefits
- Health insurance
- Prevention and wellness programs
- At least 14 weeks’ gender-neutral parental leave
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