Manager Regulatory Affairs Advertising and Promotion

Job title: Manager Regulatory Affairs Advertising and Promotion • Location: Cambridge, MA / Morristown, NJ 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. 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: • 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, 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.  • Contribute 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. About You Basic Qualifications: • Bachelor’s degree from an accredited four-year college or university; Science focus preferred, but not require   Work Experience Required: • 1+ Years experience in the following areas: • Experience within pharmaceutical or medical device Regulatory Affairs. • Successful track record with ideally 1-3 years relevant regulatory experience. • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc. • Experience in Advertising and Promotion in Regulatory required. • Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc. 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 can choose a course of action or develop the appropriate solution. • 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. • Is able to balance pr