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Job Title: Associate Director, Global Regulatory Affairs Ad-Promo (Immuno-Oncology) 

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.

The Associate Director RA serves as the regulatory lead on relative Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning assigned products appropriately while maintaining compliance with applicable FDA regulations and company policies for the advertising and promotion of prescription drugs and biologics.

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:

• Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.

• Work directly with Commercial teams from concept through review and approval, up to and including OPDP/APLB submission.

• Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials

• Work collaboratively with Compliance and Legal to ensure that materials approved by RC are used within the intended guidelines.

• Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.

• Work collaboratively with medical and scientific personnel on the development and review of materials related to advertising and promotion.

• Participate in training of sales and marketing personnel on promotional, labeling and advertising regulations.

• Serve as FDA liaison for matters related to the advertising and promotion of assigned products.

Other Position responsibilities:

• Work with other RC team members to provide input into improvement of systems and/or processes.

• Provide teams with insight into changes in the regulatory environment, including updates on FDA enforcement letters, meetings, guidance documents, and policies, etc.

• Review current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed

• This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for assigned, as well as for all verbal and written communications with OPDP/APLB reviewers

• The individual will require strong 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.

About You:

• Earned Bachelor’s degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline
• 5+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 3+ years specifically within advertising & promotion functions
• Leadership, mentoring and/or training experience within regulatory or ad/promo is preferred
• Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data.
• Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions.
• Ability to generate 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 and can modify behavior to gain acceptance of ideas or plans.
• Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally 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. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com