Talent.com
Strategic Initiative Lead - Regulatory Data, Digital and AI
Strategic Initiative Lead - Regulatory Data, Digital and AISanofi • Morristown, New Jersey, US
No longer accepting applications
Strategic Initiative Lead - Regulatory Data, Digital and AI

Strategic Initiative Lead - Regulatory Data, Digital and AI

Sanofi • Morristown, New Jersey, US
8 days ago
Job type
  • Full-time
Job description

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.

    #GD-SA

    #LI-SA

    #LI-Onsite

    #vhd

    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. (https : / / benefits.sanofiusallwell.com / fleet / public / index / ba511bf8-5c32-4828-9861-ab985fffab90 / ?cid=sanofi)

    Create a job alert for this search

    Regulatory Lead • Morristown, New Jersey, US

    Related jobs
    AI-Enabled Early Operational Strategy Leader

    AI-Enabled Early Operational Strategy Leader

    Sanofi • MORRISTOWN, NJ, US
    Full-time
    AI-Enabled Early Operational Strategy Leader.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...Show more
    Last updated: 8 days ago • Promoted
    Associate Director Regulatory Affairs – Biosimilar / BLA

    Associate Director Regulatory Affairs – Biosimilar / BLA

    Amneal Pharmaceuticals LLC • Piscataway Township, NJ, United States
    Full-time
    Regulatory expert in the area of Biosimilar / BLA submissions including strategize, compile, review and manage / lead regulatory submissions. Subject matter expert in the area of Biologics.Promotes and ...Show more
    Last updated: 30+ days ago • Promoted
    Environmental Education Instructor

    Environmental Education Instructor

    Metropolitan YMCA of the Oranges • Newton, NJ, US
    Part-time
    Description : We are an all - inclusive organization joined together by a shared commitment to nurturing the potential of kids, promoting healthy living and fostering a sense of social responsibilit...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director Regulatory Affairs

    Associate Director Regulatory Affairs

    EPM Scientific • Jersey City, NJ, United States
    Full-time
    A rapidly growing biotech is seeking an.Associate Director Regulatory Affairs.This team is composed of world-class scientists and innovators who are leading the charge of integrating advanced imagi...Show more
    Last updated: 5 days ago • Promoted
    Senior Manager, GPS Knowledge Systems

    Senior Manager, GPS Knowledge Systems

    Bristol-Myers Squibb • South River, NJ, US
    Full-time +1
    Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...Show more
    Last updated: 30+ days ago • Promoted
    Associate Director, Data Strategy and Technology U.S.

    Associate Director, Data Strategy and Technology U.S.

    Unilever • Hoboken, NJ, United States
    Full-time
    Associate Director, Data Strategy and Technology U.Associate Director, Data Strategy and Technology U.Hoboken US HQtime type : Vollzeitposted on : Heute ausgeschriebentime left to apply : Enddat...Show more
    Last updated: 12 days ago • Promoted
    Director, Division of Infectious Diseases

    Director, Division of Infectious Diseases

    Hackensack Meridian Health • Neptune Township, US
    Full-time +1
    Director, Division of Infectious Diseases.Jersey Shore University Medical Center.Hackensack Meridian Health – Neptune, New Jersey. Hackensack Meridian Health is seeking a Director, Division of...Show more
    Last updated: 11 days ago • Promoted
    Global Regulatory Affairs Device Lead (Associate Director)

    Global Regulatory Affairs Device Lead (Associate Director)

    Sanofi • Morristown, NJ, United States
    Full-time
    Global Regulatory Affairs Device Lead.Morristown, NJ or Cambridge, MA or Framingham, MA.Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to f...Show more
    Last updated: 1 day ago • Promoted
    Executive Director Global Regulatory Affairs

    Executive Director Global Regulatory Affairs

    EPM Scientific • Nutley, NJ, United States
    Full-time
    A leading global biopharmaceutical organization is seeking a seasoned.Executive Director of Global Regulatory Strategy.This is a high-impact, hands-on leadership role ideal for a strategic thinker ...Show more
    Last updated: 30+ days ago • Promoted
    Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)

    Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)

    Sanofi • Morristown, NJ, United States
    Full-time
    Director, US Regulatory Affairs - Advertising and Promotion (Hybrid).Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for pat...Show more
    Last updated: 1 day ago • Promoted
    Director of Artificial Intelligence Services

    Director of Artificial Intelligence Services

    Alpine Solutions Group • Princeton, NJ, US
    Full-time
    Position : Director / Senior Director of AI Services.Compensation : Competitive Base + bonus + FTE benefits.Location : Princeton NJ- onsite when clients are in town but primarily remote.IT experience wi...Show more
    Last updated: 4 days ago • Promoted
    Associate Director, Small Molecule Analytical Development

    Associate Director, Small Molecule Analytical Development

    Otsuka Pharmaceutical Co. • Princeton, NJ, US
    Full-time
    Associate Director, Small Molecule Analytical Development.Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs.Design and lead method ...Show more
    Last updated: 25 days ago • Promoted
    Associate Director, Advanced Analytics

    Associate Director, Advanced Analytics

    KMK Consulting Inc. • Morris Plains, NJ, United States
    Full-time
    The Associate Director, Commercial Analytics, will serve as a key client-facing leader within KMK's Commercial Analytics Center of Expertise. This role combines strategic account management with han...Show more
    Last updated: 23 days ago • Promoted
    Research And Development Scientist

    Research And Development Scientist

    Stellar Consulting Solutions, LLC • Franklin Lakes, NJ, United States
    Full-time
    The R&D Scientist II reports directly to the R&D Manager and is responsible for delivering technical excellence in the area of applied material / chemical sciences within the SM R&D organization.The ...Show more
    Last updated: 10 days ago • Promoted
    Manager, GPS Knowledge Systems

    Manager, GPS Knowledge Systems

    Bristol-Myers Squibb • Somerset, NJ, US
    Full-time +1
    Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely interesting work happens every day, in every department.From optim...Show more
    Last updated: 30+ days ago • Promoted
    Strategic Initiative Lead Regulatory Data, Digital and AI

    Strategic Initiative Lead Regulatory Data, Digital and AI

    Sanofi • Morristown, NJ, US
    Full-time
    Strategic Initiative Lead Regulatory Data, Digital and AI.Do you thrive at the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead, you will turn bold ide...Show more
    Last updated: 12 days ago • Promoted
    Regulatory Technical Writer

    Regulatory Technical Writer

    Aquestive Therapeutics • Warren, NJ, US
    Full-time
    We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulator...Show more
    Last updated: 30+ days ago • Promoted
    Executive Director of Regulatory Ad / Promo

    Executive Director of Regulatory Ad / Promo

    EPM Scientific • Bridgewater, NJ, United States
    Full-time
    Executive Director of Regulatory Affairs Ad / Promo.A global health care company, dedicated to improving people's lives through innovative solutions specialized in pharmaceuticals, medical devices, a...Show more
    Last updated: 12 days ago • Promoted
    Technical Writer / Regulatory Affairs

    Technical Writer / Regulatory Affairs

    TSR Consulting • New Brunswick, NJ, United States
    Full-time
    Please only local candidates to New Brunswick NJ.MUST have Cell Therapy or Biologics experience.Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical compa...Show more
    Last updated: 12 days ago • Promoted
    Senior Vice President, Regulatory Affairs

    Senior Vice President, Regulatory Affairs

    Rocket Pharmaceuticals • Cranbury Township, NJ, United States
    Full-time
    Work at ROCKET PHARMA and help cure rare diseases!.Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases....Show more
    Last updated: 8 days ago • Promoted