Director, US Regulatory Affairs - Advertising and Promotion

Job Title: Head of Emerging Capabilities & Strategic Transitions

Location: Morristown, NJ or Cambridge, MA

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills will be critical in helping our teams accelerate progress. Join our Regulatory Data, Digital and AI (DDAI) team as the Head of Emerging Capabilities & Strategic Transitions, and you’ll play a pivotal role in identifying, maturing, and scaling early-stage, emerging capabilities that position Sanofi’s Global Regulatory Affairs (GRA) organization for long-term success.

This role is responsible for developing a sustainable framework to incubate novel digital, data, and AI capabilities, manage transitional services, and lead strategic transitions of solutions, platforms, and services that must evolve to meet the needs of tomorrow’s regulatory landscape. You will orchestrate the lifecycle of emerging capabilities, from experimentation to institutionalization or integration, ensuring alignment with our long-term capability roadmap and resource model.

The successful candidate will bring a strategic vision, a product-oriented mindset, and the ability to collaborate cross-functionally across regulatory affairs, digital teams, and key stakeholders. Acting as a complicated-subsystem team per Team Topologies, your team will explore new ground, as well as build and maintain a system that requires heavy specialist knowledge Your team will ultimately stay deeply connected to value delivery, strategically reduce the cognitive load for stream-aligned teams, and enable the future digital transformation of global regulatory affairs.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities:

Capability Development & Transition Planning

• Lead the exploration, growth, and institutionalization or transition of new capabilities that address future regulatory needs, ensuring they are aligned to Sanofi’s DDAI roadmap and strategic goals.

Strategic Transitions & Service Evolution

• Own the transition planning and executions for strategic services, ensuring business continuity, capability uplift, while collaborating with Hubs, capability leads, and external partners.

Cross-functional Partnerships

• Collaborate closely with Engagement & Innovation, Business Optimization, Capability Development, and the Regulatory Digital teams to ensure integration, adoption, and appropriate knowledge transfer.

Talent Readiness & Future Skills

• Partner with Sanofi Learning, Hubs, and capability owners to anticipate skill requirements, contribute to key upskilling initiatives, and support the readiness of people and teams for next-generation capabilities and services.

Portfolio and Value Contribution

• Manage a portfolio of emerging capability initiatives, products, and services; track maturity, strategic fit, and readiness for transition; and ensure value capture and contribution to regulatory transformation goals.

Thought Leadership & Industry Influence

• Represent Sanofi in internal and external consortia and working groups related to emerging digital and AI capabilities in Regulatory Affairs. Provide support in shaping the future industry standard when relevant.

About you

Experience:

• Minimum of 8 years' experience working in emerging technology, digital transformation, and innovation management within the life sciences or regulated industries.

• Experience in managing the lifecycle of digital products/services—from incubation to transition or scale-up.

• Strong understanding of regulatory affairs, regulatory technology, and the evolving role of data and AI in the healthcare/pharmaceutical ecosystem.

• Monitor emerging trends, regulations, and best practices to proactively drive innovation, scalability, and efficiency throughout the organization

Soft and technical skills:

• Strategic Foresight & Execution: Ability to imagine, prototype, and operationalize future-oriented solutions and transitions.

• Team Topologies Thinking: Familiarity with complicated-subsystem and enabling team dynamics. Able to lead high-skill teams while ensuring alignment with broader stream-aligned and platform teams.

• Stakeholder Influence: Skilled in navigating cross-functional environments with influence, empathy, and clarity.

• Innovation Rigor: Strong understanding of agile delivery, lean startup, and product lifecycle thinking.

• Change Navigation: Ability to guide teams through ambiguity, scaling emerging efforts into established capabilities.

• People Management: Shaping colleagues into the best versions of themselves through appropriate mentoring, management, and upskilling.

Education:

• Advanced degree (Masters or PhD) in Information Systems, Data Science, Regulatory Affairs, Business Innovation, or related fields.

Why Choose Us?

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.