Manager Regulatory Affairs Advertising and Promotion

About the role

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.

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.

Location: Cambridge, MA / Morristown, NJ

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.

Requirements

• Bachelor's degree from an accredited four-year college or university; Science focus preferred, but not required.
• 1+ years experience in pharmaceutical or medical device Regulatory Affairs.
• Successful track record with ideally 1-3 years relevant regulatory experience.
• Experience in Advertising and Promotion in Regulatory required.
• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing, etc.

Skills

• 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 projects with day-to-day duties, ensuring participation from other members of the department as needed.
• Is able to establish priorities and timelines to effectively manage workload.
• Is able to multi-task well.
• Deals with people in an honest and forthright manner representing information and data accurately.

Benefits

• High-quality healthcare, prevention and wellness programs.
• At least 14 weeks' gender-neutral parental leave.
• Opportunities to grow your talent and drive your career through promotions or lateral moves, at home or internationally.
• Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms.
• Engage patients early in drug development and use their insights to design studies that reflect real-world needs.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.