Job Title: Regulatory Strategist

• Location: Morristown, NJ / Cambridge, MA

About the Job
 

Our team is involved in developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in the development stage of drug products.

 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

 

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.
 

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

 

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

• Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects

• Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes

• Contributes to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL

• Proactively contribute with curiosity and openness to diverse perspectives

• Emerging understanding of clinical development of drugs and/or novel biologics products

• Understanding of business acumen, leadership, influencing and negotiation skills

• Contribute to operational and compliance activities for assigned deliverables, develop, execute and maintain including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant

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

• Ability to work in electronic document management systems (e.g. Veeva vault, Plai) is a plus

• Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred

• Strong sensitivity for a multicultural/multinational environment.

 

About You

 

Education

• BS/BA degree in a scientific discipline required (e.g. Biology, Life Science, or related field); OR

• Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field).

 

Experience

• BS/BA degree in a scientific discipline or MSc in Biology, Life Science, or related field with at least 6 years of relevant pharmaceutical/biotechnology industry experience, including at least 6 years of relevant Regulatory Affairs experience; OR

• Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.

 

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

Soft Skills

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

• Sensitivity for a multicultural/multinational environment 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).

• 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.

• Demonstrated ability to manage multiple projects/deliverables simultaneously.

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.

• 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.

• Help improve the lives of millions of people globally by making drug development quicker and more effective.

• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is:

$122,250.00 - $176,583.33

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.