Head, Launch Acceleration & Regulatory Enablement - Global Launch Center

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Join Sanofi’s New Launch Excellence Center in Switzerland – Where Innovation Meets Impact

Sanofi International AG, based in Switzerland, is establishing a new transformational global commercialization center— at the cornerstone of Sanofi "Launch Powerhouse" strategy.  We are building a new world-class, centralized launch engine designed to orchestrate end-to-end commercialization for breakthrough medicines and vaccines across our Immunology and Specialty Care portfolios, that will reinforce and strengthen Sanofi’s existing launch expertise and network.

This is not a traditional pharmaceutical role. You will be part of a new pioneering, entrepreneurial entity with real decision-making authority over global launch strategies, pricing corridors, market access, lifecycle management, manufacturing, supply chain, and commercial execution. Working alongside a diverse, cross-functional team of approximately 150 dedicated professionals co-located in Switzerland, you will drive standardized, data-driven, AI-powered launch excellence at unprecedented scale.

Why co-location matters: Success in this role requires seamless, daily collaboration across medical affairs, commercial strategy, regulatory, manufacturing & supply, market access, and digital teams. By working together in one location, we eliminate silos, accelerate decision-making, foster innovation through continuous coordination, and create the agility needed to transform patient access worldwide. This is where strategy meets execution—where your work directly impacts millions of patients awaiting our next generation of therapies.

About the job

The Head, Launch Acceleration & Regulatory Enablement is a transformational leadership role responsible for re-imagining how regulatory dossiers are conceived, built, and delivered in a fast-pace pharma environment. This role brings an outside-in mindset, deliberately borrowing from nontraditional, high-velocity industries to design faster, more scalable, and more resilient regulatory operating models—while maintaining the highest standards of compliance and scientific integrity.

The role exists to collapse timelines, eliminate friction, and future-proof regulatory execution as the pipeline, indications, and geographic footprint rapidly expand. This leader positions Regulatory Affairs as a strategic accelerator of enterprise value, not a downstream constraint.

Main responsibilities:

Enterprise Dossier Acceleration Strategy & Execution

• Define and own a next-generation dossier acceleration strategy aligned with portfolio priorities, corporate growth objectives, and health authority expectations.
• Design and implement end-to-end dossier operating models built for speed, scale, and global expansion.
• Integrate dossier acceleration into portfolio planning, governance, and development decision-making.
• Ensure early dossier readiness by embedding acceleration principles upstream in development.
• This role will also be responsible for execution of activities managed by the Launch acceleration team.

Outside-In Acceleration & Paradigm Shift

• Translate concepts such as agile delivery, modular architecture, parallel workstreams, automation, digital twins, and design-for-reuse into compliant dossier development models.
• Lead rapid experimentation through pilots and proof-of-concepts, scaling what works and decisively retiring what does not.
• Act as a visible internal champion for modern regulatory thinking, shifting mindsets from document-centric to asset-centric dossier development.
• Challenge legacy regulatory assumptions

Content, Knowledge & Reuse Enablement

• Establish a single, modular regulatory backbone enabling reuse across products, indications, regions, and lifecycle events.
• Drive adoption of global core dossiers and single-source-of-truth principles.
• Ensure consistent scientific and regulatory messaging across CMC, Clinical, Nonclinical, and Safety content.

Operating Model & Process Transformation

• Identify systemic bottlenecks and lead radical simplification of dossier workflows, aggressively eliminating non-value-added steps and rework.
• Establish global standards for dossier planning, templates, timelines, and quality checkpoints.
• Partner with Digital, Data, and AI teams to enable automation and technology-driven acceleration, moving beyond tools to true operating-model change.

Cross-Functional Leadership & Influence

• Operate as an enterprise-level change leader, influencing senior leaders across Regulatory, CMC, Clinical, Quality, Safety, and external partners.
• Lead effectively in a highly matrixed, fast-evolving environment without direct authority.
• Provide clear escalation pathways and decision frameworks to keep dossiers on the critical path.

Quality, Compliance & Inspection Readiness

• Ensure acceleration is achieved with built-in quality and compliance, not downstream fixes.
• Establish metrics and dashboards to monitor speed, predictability, quality, and reuse.
• Strengthen inspection readiness through improved traceability, version control, and documentation rigor.

Talent & Capability Building

• Build, mentor, and inspire a high-performing dossier acceleration team.
• Define future-ready regulatory capabilities required to support rapid growth.
• Serve as a thought leader and coach across Regulatory Affairs.

About you

Experience and Education:

• Advanced degree in Life Sciences, Pharmacy, or related field preferred
• 10–15+ years of progressive experience in Global Regulatory Affairs, including senior leadership roles eg. Global Regulatory Leader
• Deep expertise in CTD/eCTD submissions, lifecycle management, and global regulatory frameworks
• Demonstrated success leading enterprise-level transformation, acceleration, or operating-model redesign

Soft and technical skills:

• Bold, outside-in thinker with the ability to translate external best practices into compliant regulatory solutions
• Strong executive presence with the ability to influence across senior leaders in the company
• Thrives in ambiguity; effective in build-as-you-scale environments
• Bias for action, experimentation, and measurable outcomes
• Patient-first, science-driven mindset
• Fluency in English

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. 
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. 
• Help improve the lives of millions of people globally by making drug development quicker and more effective. 
• Achieve genuine work-life balance in a supportive R&D environment.
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !