Regulatory Strategist

Job title: Regulatory Strategist

• Location: Bridgewater, NJ or Swiftwater, PA or Waltham, MA (ability to work onsite 2-3 days each week per hybrid working policy)

About the job

Sanofi is invested in reducing the RSV (Respiratory Syncytial Virus) disease burden across all vulnerable age groups. Sanofi’s ambition is to be First-in-Class and Best-in-Class in toddler protection against RSV disease. As part of the Vaccines Global Business Unit, the toddler vaccine program, currently in phase 3 stage is contributing to the continued growth of the RSV franchise that aims to protect infants, toddlers and adults. Our team is responsible to develop and execute regulatory strategy for this new asset to protect toddlers against RSV disease. The position is within the Flu/Respiratory Syncytial Virus Franchise, reporting to the Global Regulatory Lead (GRL).

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 product, 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. In this role 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.

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

• Contribute to the development of a harmonized, One Sanofiregulatory voicefor providing strategic input through participation in appropriate governance committees and forums at the direction of the GRL.

• Represent Global Regulatory Team strategic position on behalf of the GRL at regulatory forums/committees at request of GRL.

• 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.

• Identify regulatory risks and proposes mitigations.

• Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for vaccines in his/her remit.

• Participate in the development and monitoring of the global regulatory environment.

• May lead submission team or regulatory sub team to ensure regulatory filings meet the project timelines for product launch.

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

• Contribute to content and reviews regulated documents (such as clinical protocol, IB, DSUR, RMP, etc.)

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

About you

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.

Experience & Education:

• 5+ years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience.

• Significant US health authority expertise required.

• BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field. Will consider 3+ years of relevant industry experience if you possess an advanced degree (PharmD, PhD, MD or DVM).

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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