Job Title: Manager Regulatory Affairs Advertising and Promotion
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, you 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, you will 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 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 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.
- Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development and 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.
Basic Qualifications
- Bachelor’s degree in Life Sciences from an accredited four‑year college or university.
Work Experience Required
- 1‑3 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- Successful track record with ideally 1‑3 years of relevant regulatory experience.
- Experience dealing effectively with cross‑functional groups, including 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.
- Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then choosing a course of action or developing appropriate solutions.
- 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.
- Balances projects with day‑to‑day duties, ensuring participation from other members of the department as needed.
- Establishes priorities and timelines to manage workload effectively and multi‑tasks well.
- Deals with people in an honest and forthright manner, representing information and data accurately.
Benefits
- 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 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.
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.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affiliated 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, affectionate 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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