Regulatory Strategist

Company: Sanofi EU
Location: Bridgewater
Posted on: May 10, 2025

Job Description:

Job title: Regulatory StrategistLocation: Cambridge, MA (Hybrid)/ Bridgewater, NJ (Hybrid), Morristown, NJ (Hybrid)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 could be critical in helping our teams accelerate progress. Our team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage -of drug products.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?The Regulatory Strategist provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.Main Responsibilities:

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects
• Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
• Proactively contribute with curiosity and openness to diverse perspectives
• Emerging understanding of clinical development of drugs and/or novel biologics products
• Understanding of business acumen, leadership, influencing and negotiation skills
• Contribute to operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant
• Effective communication skills, specifically strong oral and written presentation skills preferred
• Ability to work in electronic document management systems (e.g. Veeva vault, Plai) is a plus
• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
• Strong sensitivity for a multicultural/multinational environment.About You:Education:
  • BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) preferredExperience:
    • At least 8 years of prior pharmaceutical/biotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and/or global) especially in development phase
    • Demonstrated experience with preparation of (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority preferred. Experience on multidisciplinary matrixed project teams (e.g. clinical study team)
    • Project leadership experience preferred Soft Skills:
      • Proactively contribute with curiosity and openness to diverse perspectives
      • Advanced understanding of clinical development of drugs and/or innovative biologics products
      • Demonstrated significant leadership experience with driving the preparation of regulatory documents (e.g. (s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing documents) and negotiating with a national/regional Health Authority
      • Demonstrates business acumen, leadership, influencing and negotiation skills
      • Demonstrated ability to use appropriate interpersonal styles and techniques to build internal networks and lead negotiations with internal and external stakeholders
      • Highly effective communication skills, specifically strong oral and written presentation skills
      • Excellent time-management and operational skills including planning and organizing
      • Demonstrated experience working in and strong knowledge of electronic document management systems to obtain and leverage regulatory deliverables (e.g. Veeva vault, Plai)
      • Demonstrated ability to handle multiple complex projects/deliverables simultaneously
      • Self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
      • Understanding of the therapeutic area marketplace and drug development
      • Strong sensitivity for a multicultural/multinational environmentWhy 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.BRIDGEWATER, NJ ONLY - Office Location Update---Sanofi's Bridgewater, NJ office is scheduled to relocate to Morristown, NJ on or around March 24, 2025 and this role will then be based in Morristown, NJ.---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-Hybrid -#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

Keywords: Sanofi EU, West New York , Regulatory Strategist, Other , Bridgewater, New Jersey