June 10, 2024


Sanofi EU Belmont, California

Job title: Associate Director, US Advertising and Promotion, Global Regulatory Affairs Location: Cambridge, MA or Bridgewater, NJ... The Associate Director, US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs). Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials.Develop solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating and managing business risks.Work directly with Commercial teams from concept through review and approval, up to and including APLB submission.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.Must be confident in their analysis and application to impacted materials to ensure compliance with the regulations.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. 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 its 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.

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