Global Regulatory Strategist

Sanofi

Global Regulatory Strategist providing regulatory expertise and guidance in oncology drug development at Sanofi. Collaborating across teams to ensure successful regulatory outcomes and timely submissions.

Posted 5/16/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesSeniorLead💰 $148,500 - $214,500 per yearWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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 committees; may be requested to lead GRT meetings
Accountable for developing HA engagement and interaction plans for assigned products, including: (1) authoring briefing documents focused on strategy and scientific content and leading team meeting preparations
May lead HA meetings and preparations as designated
May serve as regional/local regulatory lead and point of contact with Health Authorities for projects/products within remit, as needed
Leads submission teams or regulatory sub-teams to ensure timely filings that meet product launch deadlines for: Marketing applications: NDA/BLA/MAA/Extensions Clinical trial applications: IND/CTA/CTR submissions aligned with trial initiation milestones
Responsible for developing and maintaining the core global dossier; collaborating with regional leads on region-specific submissions
Leads development and implementation of expedited regulatory pathways, including: Development programs: Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), Regenerative Medicine Advanced Therapy (RMAT), PRIME Review processes: Priority Review, Project Orbis, Real-Time Oncology Review (RTOR), Conditional Approval
Executes operational and compliance activities for assigned deliverables: Generates submission content plans Tracks submission progress and milestones Leverages cross-functional teams and alliance partners as needed

Requirements

What you’ll need

BS/BA degree in a scientific discipline or MSc in Biology, Life Science, or related field is required with at least 8 years of relevant pharmaceutical/biotechnology 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 pharmaceutical/biotechnology industry experience required include at least 2 years of relevant Regulatory Affairs experience in the oncology therapeutic area.
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 strong 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.

Benefits

Comp & perks

Health insurance
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory affairsclinical developmentregulatory documents preparationsubmission content plansexpedited regulatory pathwaysFast Track DesignationBreakthrough Therapy DesignationRegenerative Medicine Advanced TherapyPriority ReviewReal-Time Oncology Review

Soft Skills

strategic inputleadershipcollaborationcommunicationcuriosityopenness to diverse perspectivesaccountabilitynegotiation

Certifications

BS/BA degreeMSc in BiologyPharmDPhDMDDVM