Job title: Senior Manager, US Advertising & Promotion, Global Regulatory Affairs

• Location: Bridgewater, NJ or Cambridge, MA

About the job

Under the direction of the Director, this individual will be responsible for providing US regulatory review and approval of promotional and other product and disease-related materials within the Medical Affairs and Commercial Operations groups. As the product expert, this individual helps to develop and implement regulatory strategies related to promotion and advertising campaigns, promotional labeling, product defense and development projects.

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

• Represent Global Regulatory Affairs (GRA) U.S. AdPromo as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of advertising, promotion, disease-state, market access, and press materials. Submit materials on form FDA 2253 when applicable. 
• Provides U.S. AdPromo strategies and opinions for investigational and marketing products to mitigate risk, provide advice and give risk/benefit analysis to meet both short- and long-term growth targets. Consults with senior management and provides input to the Global organization when necessary. 
• Contribute AdPromo expertise to the development of optimal FDA labeling on original and supplemental New Drug Applications and/or Biologics License Applications. 
• Provides input into GRA Labeling organization for labeling strategies impacting the Advertising and Promotion of investigational and marketed products. 
• Primary liaison with the Office of Prescription Drug Promotion (OPDP) and/or the Advertising and Promotional Labeling Branch (APLB) of the FDA.
• Participate in the development, monitoring and updating of standards and processes related to drug, device, and biologics AdPromo regulations and guidance’s.

About you

• Bachelor’s degree from an accredited four-year college or university (Area of specialization: Life Sciences). Advanced degree preferred.
• At least 3-5+ years of experience within pharmaceutical and/or medical device Regulatory Affairs
• Understanding of the U.S. pharmaceutical marketplace, and familiarity with medical terminology and scientific subject matter
• Have dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.
• Possess excellent verbal and written communication skills; strong interpersonal skills; good listening skills; strong negotiation skills; demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions.
• In conjunction with the Therapeutic Area Head, generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
• Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.

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!