Regulatory Strategist - Innovation Franchise

Company: Sanofi EU
Location: Cambridge
Posted on: May 22, 2025

Job Description:

Job Title: Regulatory Strategist- Innovation FranchiseLocation: Cambridge, MA, Morristown, NJAbout the JobAre 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. -The position will be based in either our Morrsitown, NJ or Cambridge, MA site as part of the Sanofi North America Regulatory Affairs Organization within GRA and will be responsible for providing US regulatory support for both development and marketed products in the Sanofi-Genzyme GBU.As a key member of the Global Regulatory Team (GRT) for the Innovation Franchise and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) will play a pivotal role in shaping regulatory strategy for novel therapies. The RS leverages their regulatory expertise to contribute to the definition and execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority (HA) interactions. This role empowers patients and providers while driving meaningful improvements in areas of high unmet medical need. In this context, the GenMed organization is seeking a bold and innovative strategic partner to join the General Medicines GBU Innovation Franchise. .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:

• Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and positions to internal business partners, including but not limited to clinical development teams, commercial teams, and the Global Regulatory Team for assigned projects within the GenMed Innovation Franchise.
• Liaise with clinical, medical, commercial, supply functions, and other internal business stakeholders in partnership with the GRL to enable successful regulatory outcomes.
• Contribute to the development of a harmonized, One Sanofi regulatory voice by providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL. May represent Global Regulatory Team's strategic position on behalf of the GRL at regulatory forums/committees at the request of GRL.
• Serve as the regional/local point of contact with Health Authorities including FDA for the GenMed Innovation Products. Contribute to the development of FDA interaction strategy, lead Health Authorities meetings, and lead the team through meeting preparations.
• Identify regulatory risks and propose mitigations in collaboration with the GRL.
• Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensure alignment with the core product labeling for GenMed Innovation Products in their remit.
• Assess and interpret the global regulatory and competitive environments, leveraging expertise in commercial competitive intelligence and other parts of GRA (e.g. Regional experts and Regulatory Science and Policy) to ensure the most robust strategy possible and determine any necessary updates to the regulatory strategy.
• Lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
• May lead submission teams or regulatory sub teams to ensure regulatory filings meet the project timelines for product launch.
• Contribute to content and review regulated documents (such as IB, PBRER, DSUR, RMP, etc.).
• Support operational and compliance activities for assigned regulatory deliverables and develop regulatory submission planning, including submission tracking in the electronic document management system.
• Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with GRA Strategy and Business Optimization.About YouBasic Qualifications:
  • BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, or MSc in Biology, Life Science, or related field) preferred.
  • At least 6 years or prior pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience in the United-States.
  • Significant track record of US regulatory expertise required (demonstrated experience with preparation of NMAs, LCM activities, briefing documents) and negotiating with the US FDA.
  • Experience with acceleration pathways (Orphan Drug, Breakthrough Therapy---), pediatric and clinical trial regulations as well as novel methodologies for regulatory decision making (RWE, patient focused drug development).
  • Digital training and understanding on Sanofi Digital Transformation (AI role)
  • Project leadership experience preferred.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.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

Keywords: Sanofi EU, Worcester , Regulatory Strategist - Innovation Franchise, Other , Cambridge, Massachusetts