Sanofi
healthcare
GlobalRegulatoryStrategist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Global Regulatory Strategist at Sanofi. Skills: regulatory strategy, Health Authority engagement, regulatory submissions. Provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams. Accountable for developing HA engagement and interaction plans for assigned products”
What You'll Achieve.
ensure delivery of business objectives; enable successful regulatory outcomes; ensure timely filings that meet product launch deadlines; Help improve the lives of millions of people globally by making drugdevelopment quicker and more effective.
Industry & Context.
What They're Looking For.
Must Have
BSA degree in a scientific discipline or MSc in Biology, Life Science, or related field is required with at least 8 years of relevant pharmaceuticaliotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience in the oncology therapeutic area OR Advanced degree (PharmD, PhD, MD or DVM) with at least 4 years of regulatory or relevant pharmaceuticaliotechnology industry experience required include at least 2 years of relevant Regulatory Affairs experience in the oncology therapeutic area.
Nice to Have
Understanding of clinical development of drugs and/or innovative biologics products is preferred., Demonstrated 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 is desirable., Experience working in and knowledge of electronic document management systems (e. g. Veeva Vault RIM, Plai) is desirable, Experience working with AI platforms when establishing regulatory environment, current industry best practices, etc. is a plus.
What You'll Do.
Provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams
Accountable for developing HA engagement and interaction plans for assigned products
Leads submission teams or regulatory sub-teams to ensure timely filings that meet product launch deadlines
Responsible for developing and maintaining the core global collaborating with regional leads on region-specific submissions
Leads development and implementation of expedited regulatory pathways
Executes operational and compliance activities for assigned deliverables
How You'll Work.
Team & Collaboration
Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and positioning to internal business partners, including clinical development teams, commercial teams, and the Global Regulatory Team (GRT) for assigned projects; Liaises with nonclinical, clinical, CMC, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes; Contributes to a harmonized, One Sanofi regulatory voice through participation in appropriate committees and forums, at the direction of the GRL; Proactively contributes to the GRT with curiosity and openness to diverse perspectives, providing strategic input on the Target Product Profile (TPP), business planning, governance, and may be requested to lead GRT meetings
Communication Scope
Effective communication skills; oral and written presentation skills
Process & Methodology
Leads submission teams or regulatory sub-teams, Tracks submission progress and milestones
Full Job Description
**Job title:** Global Regulatory Strategist * **Grade** : L3 * **Location:** Morristown, NJ **About the job** Our team is involved in developing regulatory product strategies for the oncology 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 delivery of business objectives. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. **About Sanofi** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. **Main responsibilities:** **Cross - Functional Collaboration:** * Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and positioning to internal business partners, including clinical development teams, commercial teams, and the Global Regulatory Team (GRT) for assigned projects * Liaises with nonclinical, clinical, CMC, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes * Contributes to a harmonized, One Sanofi regulatory voice through participation in appropriate commi
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