Regulatory Strategist mRNA Vaccines at Sanofi, Apply Now!

Regulatory Strategist mRNA Vaccines – at Sanofi, Apply Now!

Looking to shape the future of global health? Sanofi is hiring a Regulatory Strategist for its pioneering mRNA vaccine team in Swiftwater, PA or Morristown, NJ. This is your chance to contribute to cutting-edge regulatory strategies supporting vaccine breakthroughs in Influenza, RSV, and more. Be part of a team transforming science into real-world solutions while navigating the evolving regulatory landscape in mRNA technology.

Job Title: Regulatory Strategist – mRNA Vaccines

Location: Swiftwater, PA or Morristown, NJ

Req I’d: R2796307

Main Responsibilities

• The Regulatory Strategist (RS) enables the Global Regulatory Lead (GRL) providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams and the Global Regulatory Team for assigned projects

• The RS liaises with clinical, medical, commercial, and other internal business stakeholders to enable successful regulatory outcomes

• The RS contributes to the development of a harmonized, one regulatory voice for providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL

• The RS may represent Global Regulatory Team strategic position on behalf of the GRL at regulatory forums/committees at request of GRL

• The RS serves as point of contact with Health Authorities for vaccine candidates in his/her remit in US

• The RS contributes to the development of global Health Authorities engagement and interactions plans for their assigned products in collaboration with the regulatory and cross-functional team members. This includes the authoring of the briefing document focused on the strategy and scientific content, and leading the cross-functional team through meeting preparation. The RS attends and may lead Health Authorities meetings as designated

• The RS identifies regulatory risks and proposes mitigation plans to cross-functional teams as appropriate

• The RS ensures alignment between the Regulatory Strategy and the core product labeling for vaccine candidates in his/her remit

• The RS leads submission team or regulatory sub team to ensure regulatory filings meet the project timelines

• The RS may lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation

• The RS contributes to content and review of regulated documents (IB, PBRER, DSUR, RMP, etc)

• The RS supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management

• The RS participates in the development and monitoring of the global regulatory environment

Knowledge, Skills & Competencies:

• Proactively contributes with curiosity and openness to diverse perspectives

• Demonstrated ability to handle multiple products/deliverables simultaneously

• Demonstrates business acumen, leadership, influencing and negotiation skills

• Effective communication skills, specifically strong oral and written presentation skills

• Understanding of clinical development of drugs, biological products. Vaccines is a plus

• Ability to work in electronic document management systems, e.g., Veeva Vault is a plus

• Strong sensitivity for a multicultural/multinational environment

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 8 years prior pharmaceutical/biotechnology industry experience, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global)

• Significant track record of US regulatory expertise required (demonstrated experience with preparation of BLA/NDA, INDs, FDA meeting briefing documents)

• Previous experience with novel technology platforms and/or accelerated regulatory pathways would be a plus

• 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 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

APPLY ONLINE HERE 

Keywords: Regulatory Strategist, mRNA Vaccines, Sanofi, Job Posting, Global Regulatory Lead