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?

Main Responsibilities

Innovation Execution & Validation

• 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 .

Leadership & Influence

• 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.

Cross-Functional Collaboration

• 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.

Strategic Enablement & Portfolio Impact

• 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.

About You

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Competencies and Skills

• 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 cross-functional partners.
• Proven track record of managing complex, high-risk initiatives in global or matrixed pharma/biotech environments.
• Experience framing problems, validating assumptions, and building compelling investment cases.
• Interpersonal Influence: Able to secure buy-in across diverse stakeholders, from end users to senior leaders.
• Growth Mindset: Comfortable with experimentation, uncertainty, and continuous learning.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Drive impact at scale: Shape the next wave of regulatory innovation, from bold ideas to scalable capabilities.
• Be at the frontier: Lead initiatives where uncertainty is high but potential impact is transformative.
• Grow beyond boundaries: Build influence across regulatory affairs, digital, and senior leadership communities.
• Enable future-ready GRA: Help design the workforce, systems, and processes that will define regulatory science in the next decade.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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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.