Regulatory Strategist– Vaccines at Sanofi, Lifescience candidates Apply Now
Are you an experienced Regulatory Affairs professional with a BS/BA degree in a relevant scientific discipline and at least 6 years in the pharmaceutical/biotechnology industry, particularly with vaccines? Join our innovative global healthcare company, a leading provider of vaccines, as a Regulatory Strategist – Vaccines in either Swiftwater, PA or Morristown, NJ, USA. If you are ready to shape the future of medicine by developing and executing regulatory strategies for vaccines, we encourage you to apply!
About the Company:
We are an innovative global healthcare company dedicated to staying ahead of infectious diseases by delivering over 500 million vaccine doses annually. Our diverse teams across different countries are committed to exploring new technologies to safeguard public health and well-being. Join us in pursuing scientific breakthroughs every day to make a meaningful impact on millions of patients worldwide.
Job Details
- Job Title: Regulatory Strategist – Vaccines
- Locations: Swiftwater, PA / Morristown, NJ
- Time Type: Full-time
- Posted on: Posted Yesterday
- Time Left to Apply: End Date: August 21, 2025 (30+ days left to apply)
- Job Requisition ID: R2798367
About the Job
Are 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 team is involved in developing and executing regulatory strategies for vaccines in post marketing and in life cycle development stages to support and drive the growth of the Vaccines Global Business Unit (GBU).
The position is reporting to the PPH Global Regulatory Lead but may also support other Therapeutic areas based on business needs.
Main Responsibilities
As a Regulatory Strategist – Vaccines, your main responsibilities will include:
- Enabling the Global Regulatory Lead (GRL) by providing quality regulatory input and position to internal business partners.
- Liaising with internal stakeholders to enable successful regulatory outcomes.
- Serving as a regional/local point of contact with Health Authorities.
- Identifying regulatory risks and proposing mitigations.
- Leading submission teams to ensure regulatory filings meet project timelines.
- Contributing to the development of Global Regulatory Project Strategy (GRPS).
About You
Knowledge, Skills & Competencies:
- Proactively contributes with curiosity and openness to diverse perspectives.
- Effective communication skills, specifically strong oral and written presentation skills.
- Ability to work in electronic document management systems, e.g., Veeva Vault is a plus.
Experience & Education:
- BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM 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 (regionally and/or global).
- Significant track record of US, EU and International regulatory expertise required (demonstrated experience with preparation of NMAs, LCM activities, EU/US briefing documents) and negotiating with a national/regional HA preferred. Experience with China and Japan is a plus.
- 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 1 through promotion or lateral move. Enjoy a thoughtful rewards package that recognizes your contribution and amplifies your impact.
Keywords: Regulatory Strategist, Vaccines, Global Healthcare, Pharmaceutical Industry, Regulatory Affairs, Vaccine Development
