Regulatory Strategist - mRNA Vaccines

Job Title: Regulatory Strategist - mRNA Vaccines

Location: Swiftwater, PA or Morristown, NJ

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. 

Sanofi has established an mRNA Center of Excellence (CoE) and is actively developing mRNA-based vaccines which have the potential to be first and best-in class products in Influenza, Acne, Chlamydia and Respiratory Syncytial Virus (RSV). The Regulatory Affairs mRNA team is responsible for developing and executing cutting-edge regulatory strategies that enable successful product development and market access, while ensuring compliance with evolving global regulations specific to mRNA technologies. The team serves as the critical interface between R&D, manufacturing, and Health Authorities to navigate the unique regulatory challenges of this innovative therapeutic platform. The position is within the mRNA Therapeutic Area, reporting to Global Regulatory Lead.

As a key member of the Global Regulatory Team, the mRNA Regulatory Strategist is a strategic partner to contribute to the definition and execution of innovative regulatory approaches to accelerate the development and approval of two mRNA vaccine candidates while navigating the evolving regulatory landscape for this cutting-edge technology. This role requires a strategic mindset to balance scientific innovation with regulatory challenges.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

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

About You

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.​

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.