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

Sanofi

. Lead organizational design, people development, supervision, coaching, mentoring, resource allocation, recruitment, retention, talent development, succession planning and metrics for the expert unit .

Posted 11/4/2026full-timeUnited StatesLead💰 $266,250 - $384,583 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in regulatory affairs, particularly in Model-Informed Drug Development (MIDD) and innovative endpoint strategies. Proven ability to lead teams, drive cross-functional collaboration, and engage effectively with regulatory authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceModel-Informed Drug Development (MIDD)Leadership in Team DevelopmentRegulatory Submission ExpertiseCommunication and Influencing Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Modeling and SimulationNovel Endpoint DevelopmentRegulatory Strategy FrameworksRegulatory Validation ProjectsHealth Authority Engagement PlansRisk Assessment and MitigationRegulatory Pathways KnowledgeAdvanced Modeling ApproachesRegulatory Trends MonitoringTraining Curriculum Development

Soft Skills

Coaching and MentoringCross-Functional CollaborationIndependence in ThinkingPartnership BuildingEffective Communication

Certifications & Qualifications

Bachelor's DegreeAdvanced Degree (Masters, Pharm D, PhD)

Industry Keywords

Regulatory AgenciesFDA MIDD Pilot ProgramReal-World EvidenceCenter of ExcellenceSOPsKnowledge ManagementScientific Working GroupsIndustry ConsortiaTranslational MedicineClinical Development

About the role

Key responsibilities & impact

Lead organizational design, people development, supervision, coaching, mentoring, resource allocation, recruitment, retention, talent development, succession planning and metrics for the expert unit
Resolve and advise on complex global organizational and regulatory/technical issues related to model-enabled development, regulatory real-world evidence and novel endpoint strategies
Establish the team as a center of excellence for model-enabled regulatory strategies and submissions
Oversee comprehensive regulatory strategy frameworks for Model-Enabled Drug Development across all development phases
Lead regulatory validation projects from concept to approval, including C-Peptide endpoint validation and iBox
Partner with Global Regulatory Leads and R&D functions to implement model-enabled and real-world evidence regulatory strategies
Integrate regulatory considerations early in development projects and identify, communicate and mitigate risks
Oversee strategic negotiations and engagement with worldwide Regulatory Agencies, including FDA and EMA
Develop and implement health authority engagement plans for innovative regulatory strategies
Represent Sanofi at Agency meetings and scientific working groups
Build specialized regulatory expertise and oversee best practices, SOPs, training materials and knowledge-management platforms
Develop and deliver training curricula and capability-development programs
Monitor and communicate Health Authority thinking, regulatory trends and paradigm shifts
Lead externally through participation in industry consortia, working groups and professional associations
Oversee preparation, review and approval of model-enabled regulatory submissions, real-world evidence packages and novel endpoint validation packages
Drive cross-functional project delivery through matrix collaboration and establish governance and decision-making processes

Requirements

What you’ll need

Minimum 10-15 years of regulatory affairs experience with demonstrated progression in regulatory roles and successful regulatory authority interactions
Direct experience with Model-Informed Drug Development (MIDD), pharmacometrics, modeling and simulation, and/or novel endpoint development highly desirable
Proven track record of successful regulatory submissions involving advanced modeling approaches or innovative endpoints
Leadership experience building and developing specialized teams, including organizational design, people leadership and development, recruitment, retention, talent management and succession planning
Experience establishing centers of excellence or expert units highly valued
Ability to lead through influence in a matrix organization and drive cross-functional collaboration
Strong knowledge of model-enabled frameworks, including the FDA MIDD Pilot Program
Knowledge of regulatory pathways for novel endpoint validation and key Agency thinking and trends in regulatory science innovation
Ability to resolve complex strategic technical and regulatory issues related to modeling, simulation and endpoint development
Experience working with or for a Regulatory Health Authority helpful but not essential
Bachelor's degree required
Advanced degree (Masters, Pharm D, PhD) in a quantitative science or health sciences field, or equivalent, highly desirable
Excellent communication and influencing skills
Ability to translate complex technical concepts for diverse audiences
Ability to build and maintain partnerships with health authorities, R&D functions and external stakeholders
Ability to assess regulatory risks and opportunities, develop pragmatic and innovative solutions, and anticipate regulatory trends
Independence in thinking, anticipatory foresight, and ability to communicate effectively to broad, sophisticated audiences
Experience building and maintaining partnerships across functions, particularly Translational Medicine, Clinical Development, Biostatistics and Medical Affairs
Proven ability to drive knowledge sharing and capability building across organizations
10% domestic and international travel expected

Benefits

Comp & perks

Opportunities for promotion or lateral career moves, at home or internationally
Rewards package recognizing contribution and impact
Health and wellbeing benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Employee benefit programs
Equal Opportunity employment