Launch Acceleration and Regulatory Enablement Lead

Sanofi

. Lead and deliver submission acceleration initiatives across all Global Business Units .

Posted 10/19/2026full-timeUnited StatesSenior💰 $206,250 - $297,917 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global Regulatory Affairs with a strong focus on submission preparation, execution, and strategy development. Proficient in leveraging digital tools and process improvement methodologies to enhance regulatory workflows and drive submission acceleration.

Highest-signal resume keywords

Global Regulatory Affairs ExpertiseSubmission Preparation and ExecutionRegulatory Frameworks KnowledgeProcess Improvement and AutomationCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Submission PreparationLifecycle Management SubmissionsModular Dossier ArchitectureSubmission Planning ToolsRegulatory Intelligence TranslationKPI TrackingChange ManagementTraining DevelopmentSubmission Acceleration StrategiesHealth Authority Guidance

Soft Skills

Collaborative PartnershipExecutive PresenceAdaptabilityInnovation and CuriosityQuality Mindset

Tools & Technologies

Digital ToolsAutomation ToolsSubmission Excellence PlatformChange Management ToolsTraining Tools

Industry Keywords

ICH GuidelinesEU RegulationsUS FDA RequirementsGlobal Regulatory FrameworksCross-Functional R&D TeamsPatient-First OrientationAgile MethodologiesMatrixed EnvironmentsScientific DisciplineLife Sciences

About the role

Key responsibilities & impact

Lead and deliver submission acceleration initiatives across all Global Business Units
Develop and drive submission acceleration strategies and levers with cross-functional R&D Global Project Teams and submission teams
Define and embed end-to-end submission preparation best practices, tools, templates, and guidance
Design and deliver training on submission acceleration tools, processes, and mindset shifts
Co-develop change management tools and coach teams through new ways of working
Drive modernization and reuse of modular regulatory content, including CTD modules, core dossier sections, and bridging documents
Apply single-source-of-truth principles across CMC, Clinical, Nonclinical, and Safety content
Support global core dossier templates and standards and their incorporation into new marketing authorization processes
Monitor health authority expectations, guidance documents, and industry best practices
Translate regulatory intelligence into actionable insights
Co-design and run pilots and proof-of-concepts for acceleration levers
Identify bottlenecks, test practical solutions, and lead rollout of improved processes
Support adoption of AI, automation, and digital tools in dossier workflows
Contribute to development of a Submission Excellence Platform
Potentially act as Global Process Lead for New Marketing Authorisation processes
Partner with Global Regulatory Leaders and cross-functional R&D teams across CMC, Clinical, Nonclinical, Safety, Commercial, Translational Medicine, and Quality
Prepare and present materials for senior R&D governance forums and internal decision-making bodies
Co-lead the cross-functional R&D Submission Excellence network
Own metrics and KPI tracking for speed, predictability, quality, and reuse
Contribute to Sanofi’s mission of accelerating medicine development and regulatory authorizations

Requirements

What you’ll need

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, a Scientific discipline, or a related field
10+ years of experience in Global Regulatory Affairs
Demonstrated expertise leading global regulatory submission preparation and execution team(s)
Solid understanding of global regulatory frameworks, including ICH guidelines, EU, US FDA, and other major health authority requirements
Hands-on experience with lifecycle management submissions, including variations, renewals, and line extensions, across multiple regions
Familiarity with modular dossier architecture, content reuse strategies, and submission planning tools
Experience delivering results in matrixed, cross-functional environments with multiple simultaneous workstreams
Exposure to or interest in process improvement, agile methodologies, or digital/automation tools applied to regulatory workflows is a strong asset
Fluent in English, spoken and written
Advanced degree (MSc, PhD, PharmD) preferred
Competencies in global regulatory strategy, training and facilitation, executive presence, leading without authority, innovation and curiosity, collaborative partnership, quality mindset, execution excellence, adaptability, patient-first orientation, and digital fluency

Benefits

Comp & perks

Opportunities for promotion or lateral career moves, domestically or internationally
Rewards package recognizing employee contributions
Health and wellbeing benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Opportunities to work with cutting-edge AI, data, and digital platforms
Equal Opportunity employment