Manager Regulatory Affairs Advertising and Promotion

Job Title Manager Regulatory Affairs Advertising and Promotion Location Morristown, NJ & Cambridge, MA Overview 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 direction from the Therapeutic Area Head, you will conduct the independent review of advertising, promotional, communications and other materials, help develop and implement regulatory strategies for promotion and advertising campaigns, and serve as regulatory lead for product launches. As the product A&P expert, you will contribute to the development and implementation of regulatory strategies for labeling, product defense, and development projects and be the primary liaison with FDA on advertising and promotional compliance matters. 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 on 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. Participates as 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. Contributes 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. Qualifications Basic Qualifications Bachelor’s degree in Life Sciences from an accredited four‑year college or university. Experience 1–3 years of experience in pharmaceutical or medical device Regulatory Affairs. Successful track record with ideally 1–3 years of relevant regulatory experience. Experience dealing effectively with cross‑functional groups, which may include Medical, Legal, Marketing, etc. Experience in Advertising and Promotion in Regulatory required. 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. Ability to analyze data from different sources to draw conclusions and then choose a course of action or develop the appropriate solution. Develops collaborative relationships to facilitate the accomplishment of work goals and proposes innovative solutions in work situations. 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 Sanofi values. Ability to balance projects with day‑to‑day duties, establish priorities and timelines to effectively manage workload, and multi‑task well. Deals with people in an honest and forthright manner representing information and data accurately. Eligibility North America Applicants Only. US and Puerto Rico Residents Only. Salary Salary range: $122,250.00 – $176,583.33. All compensation will be determined commensurate with demonstrated experience. Equal Opportunities Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and 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 identity or expression; sexual orientation; disability; veteran or 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. #J-18808-Ljbffr