R&D
Wo deine Neugier die Wunder der Wissenschaft antreibt

Job Title: Manager Regulatory Affairs

Location: Morristown, NJ Cambridge, MA

About the Job

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.

With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.  As the product A&P expert, contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects.   Serve as the primary liaison with FDA, for assigned products, on matters related to advertising and promotional compliance matters.

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:

• Identifies product specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.

• Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.

• Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.

• Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.

• Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs. 

• Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.

• Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.

• Performs other duties as assigned.

About You

Basic Qualifications:

• Bachelor’s degree in Life Sciences from an accredited four-year college or university.

Work Experience Required:

• 1-3 Years experience in the following areas:

  • Experience within pharmaceutical or medical device Regulatory Affairs.

  • Successful track record with ideally 1-3 years relevant regulatory experience.

  • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.

Knowledge, Skills and Equivalent Experience:

• Knowledge and understanding of complex medical and scientific subject matter.

• Ability to work well within cross-functional teams.

• Demonstrates solid oral communication and writing skills.

• Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology.

• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.

• Develops collaborative relationships to facilitate the accomplishment of work goals.

• Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.

• Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans.

• Can build collaborative internal networks to obtain cooperation.

• Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.

• Is able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.

• Is able to establish priorities and timelines to effectively manage workload. Is able to multi-task well.

• Deals with people in an honest and forthright manner representing information and data accurately.

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.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.