Job title: Regulatory Strategist - Vaccines

• Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA

About the job

You will play a crucial part in developing and executing regulatory strategies for Rabies vaccines in post marketing and in development stages to support the Traveler Endemic Franchise business, driving the growth of the Vaccines Global Business Unit. The new generation of rabies vaccine to be registered worldwide, the associated challenges and the best regulatory pathways to be developed will make the difference. The position is within the Covid and Traveler Endemic Therapeutic Area, reporting to the Rabies Global Regulatory Lead.

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?

Main responsibilities

• As a key member of the Global Regulatory Team, the Regulatory Strategist (RS) is the strategic partner to contribute to the definition of the global regulatory strategy for assigned products, to enable and drive its execution in US, EU and worldwide countries, including Health Authority interactions.

• As the RS, you will lead submission team or regulatory sub teams to ensure regulatory filings meet the project timelines for product launch (e.g. New rabies vaccine CTD preparation and submission in US).

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

• You will enable the Global Regulatory Lead (GRL) to provide regulatory position to support business needs, as well as the regulatory team members to provide the necessary information for their responsible accountabilities.

• Liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders to enable successful regulatory outcomes.

• You will serve as point of contact with Health Authorities for vaccines in his/her remit in US.

• Contribute to the development of global Health Authorities interaction strategy in collaboration with the regulatory team members, attends and may lead Health Authorities meetings, and leads the team through meeting preparations.

• You will be responsible for the development of Global Regulatory Project Strategy and ensure alignment with the core product labeling for vaccines.

• You will contribute to content and reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc.)

• Supports operational and compliance activities for assigned regulatory deliverables and develops regulatory submission planning, including submission tracking in the electronic document management system.

About you

• BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 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.

• Significant US regulatory expertise required.

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

• Demonstrated business acumen, leadership, influencing and negotiation skills.

• Ability to handle multiple products/deliverables simultaneously.

• Strong sensitivity for a multicultural/multinational environment.

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

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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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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !