Job title: Global Regulatory Strategist
- Location: Morristown, NJ/ Cambridge, MA
About the jobOur team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development stage of drug products. 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.
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 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
Health Authority (HA) Engagement:- 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
Regulatory Submissions & Operations:- 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
About youExperience
- 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.
Technical Skills
- 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.
Soft Skills
- Effective communication skills, specifically strong oral and written presentation skills.
- Sensitivity for a multicultural/multinational environment
- Emerging business acumen, leadership, influencing and negotiation skills.
- Ability to use appropriate interpersonal styles and techniques to build internal and external networks and lead discussions with internal and external stakeholders.
Why Choose Us- Bring the miracles of science to life alongside a supportive, futurefocused 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.
- Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
- Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
- Help improve the lives of millions of people globally by making drugdevelopment quicker and more effective.
The salary range for this position is:
$148.500,00 - $214.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
