Strategic Initiative Lead – Regulatory Data, Digital and AI

Job Title: Strategic Initiative Lead – Regulatory Data, Digital and AI

Location
:
Cambridge, MA or Morristown, NJ

About the Job

Do you thrive at the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead, you will turn bold ideas into validated opportunities, transforming concepts into business-ready solutions that future-proof Sanofi’s Global Regulatory Affairs (GRA).

Reporting to the Head of Engagement & Innovation, you will lead initiatives at the validation and acceleration stages of our innovation funnel, working closely with Innovation Leads, Business Process Owners, Capability Heads, and Digital partners. By applying your deep regulatory knowledge and proven leadership skills, you will guide high-risk, high-reward initiatives through uncertainty - framing the right problems, validating assumptions, and building the case for scale.

This role is ideal for an experienced regulatory affairs professional who has expanded into digital transformation, program leadership, and cross-functional influence. You will be a visible ambassador of innovation, representing initiatives with senior leaders, translating complex concepts for diverse audiences, and ensuring investment decisions are backed by rigorous validation.

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?

• Lead selected initiatives from incubation through validation and acceleration, designing success criteria, validation metrics, and learning agendas.
• Translate early concepts into tangible pilots, proofs of value, or minimum viable capabilities that can secure time and budget for scaling.
• Reframe business problems by leveraging regulatory SME expertise to ensure initiatives move from good to great.

• Represent initiatives with senior stakeholders, clearly communicating assumptions, progress, risks, and opportunities.
• Influence decision-makers with strong business cases built on regulatory insight, user needs, and measurable outcomes.
• Serve as a visible champion of innovation within GRA and with external partners.

• Partner with Innovation Leads, Capability Heads, and Digital teams to ensure smooth handoffs across the innovation funnel.
• Co-create with Innovation Leads, Capability Analysts, and Process Owners to refine problem statements, requirements, and adoption pathways.
• Connect with external partners, vendors, and regulators to stress-test ideas and anticipate future directions.

• Actively shape the Engagement & Innovation portfolio by screening, assessing, and prioritizing incoming demand.
• Contribute to the continuous improvement of the innovation funnel, ensuring scalability, compliance, and measurable value realization.
• Provide thought leadership on regulatory innovation trends, risks, and opportunities.

• 8+ years of experience in Regulatory Affairs or related area, with demonstrated impact in digital transformation, capability building, or strategic programs.
• Bachelors’ degree in a Life Sciences, Pharmacaeutical, Regulatory Affairs, Digital Health, or related field.

• Advanced degree (Masters, PhD) in a Life Sciences, Pharmaceutical, Regulatory Affairs, Digital Health, or related field.
• Certifications in project management, innovation frameworks (Lean Startup, Strategyzer, Design Thinking, Strategic Foresight), or regulatory science are a plus.

• Regulatory Affairs Expertise:
  Deep understanding of regulatory information management, submissions, labeling, or lifecycle management.
• Program Leadership:
  Strong project/program management skills, with the ability to handle ambiguity and pivot quickly.
• Strategic Communication:
  Skilled at simplifying complex concepts and tailoring messages to executives, SMEs, and…