Senior Manager, Regulatory Affairs – Advertising and Promotion

• Conduct independent review of advertising, promotional, communications, and other materials
• Help develop and implement regulatory strategies for promotion and advertising campaigns
• Serve as regulatory lead for product launches
• Contribute to regulatory strategies for labeling, product defense, and development projects
• Serve as primary liaison with the FDA for assigned products on advertising and promotional compliance matters
• Identify product-specific or therapeutic-area advertising and promotion issues and propose and implement solutions
• Advise clients on risks and benefits of different strategies to support sound business decisions
• Oversee successful implementation of regulatory strategic objectives and projects with minimal supervision
• Participate as Regulatory representative on brand teams and Review Committees for commercial and medical materials
• Provide guidance to commercial and R&D groups to maximize competitive impact of product development, promotion, advertising, and reimbursement
• Provide input to Global organization on domestic regulatory strategies for in-line products through life-cycle management programs
• Contribute advertising and promotion expertise to optimal labeling for new and supplemental new drug applications
• Develop product-specific regulatory strategies to mitigate risk and provide risk/benefit analysis with brand team management
• Perform other duties as assigned

• Bachelor’s degree in Life Sciences from an accredited four-year college or university
• 3+ years of experience in pharmaceutical or medical device advertising and promotional review
• Ideally 1–3 years of relevant regulatory experience
• Experience working effectively with cross-functional groups, including Medical, Legal, and Marketing
• Knowledge and understanding of complex medical and scientific subject matter
• Strong oral communication and writing skills
• Understanding of the U.S. pharmaceutical marketplace
• Familiarity with medical terminology
• Ability to analyze data from different sources, draw conclusions, and choose appropriate courses of action or solutions
• Ability to develop collaborative relationships and internal networks
• Ability to propose innovative solutions
• Ability to use interpersonal styles and techniques to gain acceptance of ideas or plans
• Unquestionable ethics, professional integrity, and personal values consistent with Sanofi values
• Ability to balance projects with day-to-day duties and establish priorities and timelines
• Ability to multitask
• Ability to represent information and data accurately
• Applicants must be residents of the United States or Puerto Rico

Demonstrates expertise in regulatory strategies for advertising and promotional compliance within the pharmaceutical industry, with a strong focus on collaboration across cross-functional teams and effective communication. Capable of conducting thorough reviews and providing strategic guidance to maximize product impact and compliance.

• Regulatory Strategies Development
• Advertising and Promotional Review
• Cross-Functional Collaboration
• Risk/Benefit Analysis
• FDA Liaison Experience

• Regulatory Compliance
• Advertising Review
• Promotional Material Review
• Risk Mitigation Strategies
• Data Analysis
• Labeling Expertise
• Product Launch Strategies
• Medical Terminology
• Life Cycle Management
• Pharmaceutical Knowledge

• Strong Oral Communication
• Writing Skills
• Interpersonal Skills
• Innovative Problem Solving
• Project Management

• Pharmaceutical Industry
• Medical Device
• U.S. Pharmaceutical Marketplace
• Regulatory Affairs
• Promotional Compliance
• Cross-Functional Teams
• Brand Management
• Commercial Materials
• R&D Guidance
• Ethics and Integrity