Global Regulatory Strategist

Role Overview

• 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

• 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.

Tech Stack

• Vault

Benefits

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