About the Job

• Location: Bridgewater NJ, Swiftwater PA, or Waltham MA
• Candidate must be able to accommodate a hybrid working arrangement. This is not a fully remote position.

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.

Our Team

The team is involved in developing and executing regulatory strategies for vaccines in the covid, endemic and new technologies area. The primary responsibilities of the position will be in the post marketing and life cycle management of currently licensed vaccines to support the growth of the Vaccines Global Business Unit. We are seeking a Regulatory Strategist with a strong interest in digital tools and technologies to join our team. The ideal candidate will have a deep understanding of the pharmaceutical industry and regulatory affairs, coupled with a passion for digital innovation. This role provides the opportunity to work at the forefront of digital innovation in the pharmaceutical industry.

The position is within the Covid/Endemic and New Technology Therapeutic Area (TA) reporting to a TA Global Regulatory Lead.

Main Responsibilities:

As a key member of the Global Regulatory Team, the Regulatory Strategist 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.

The Regulatory Strategist provides regulatory expertise to the Global Regulatory Team and cross-functional teams to ensure the delivery of business objectives.

• A key function of this Regulatory Strategist (RS) role will be to collaborate within a joint venture with a partner vaccine company to oversee the lifecycle management of a globally licensed vaccine.

• The Regulatory Strategist (RS) enables 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.

• The RS liaises with clinical, medical, commercial, supply functions, and other internal business stakeholders to enable successful regulatory outcomes. The RS contributes to the development of a harmonized, 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 vaccines in his/her remit in US.

• The RS contributes 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.

• The RS identifies regulatory risks and proposes mitigations.

• The RS contributes to the development of Global Regulatory Project Strategy and ensures alignment with the core product labeling for vaccines in his/her remit.

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

• 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 reviews regulated documents (such as IB, PBRER, DSUR, RMP, etc).

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

Knowledge, Skills & Competencies:

• Proactively contributes with curiosity and openness to diverse perspectives.

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

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

• 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.

• Demonstrated ability to handle multiple products/deliverables simultaneously.

• Strong sensitivity for a multicultural/multinational environment.

• Strong interest in digital tools including artificial intelligence tools.

• Ability to adapt to new digital tools and technologies quickly.

Responsibilities linked to digital:

• Leverage digital tools including GenAI, to streamline regulatory processes, improve efficiency and enhance strategic input.

• Stay updated on emerging digital trends and technologies in the pharmaceutical industry - in particular in the regulatory environment.

• Collaborate with cross-functional teams to ensure compliance with digital regulations.

• Provide digital support to team members as needed.

• Share knowledge and support within the team

About you

Experience & Education:

• 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.

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!