Senior Manager, Regulatory Affairs – Advertising and Promotion

Conduct independent review of advertising, promotional, communications, and other materialsHelp develop and implement regulatory strategies for promotion and advertising campaignsServe as regulatory lead for product launchesContribute to regulatory strategies for labeling, product defense, and development projectsServe as primary liaison with the FDA for assigned products on advertising and promotional compliance mattersIdentify product-specific or therapeutic-area advertising and promotion issues and propose and implement solutionsAdvise clients on risks and benefits of different strategies to support sound business decisionsOversee successful implementation of regulatory strategic objectives and projects with minimal supervisionParticipate as Regulatory representative on brand teams and Review Committees for commercial and medical materialsProvide guidance to commercial and R&D groups to maximize competitive impact of product development, promotion, advertising, and reimbursementProvide input to Global organization on domestic regulatory strategies for in-line products through life-cycle management programsContribute advertising and promotion expertise to optimal labeling for new and supplemental new drug applicationsDevelop product-specific regulatory strategies to mitigate risk and provide risk/benefit analysis with brand team managementPerform other duties as assignedRequirementsBachelor’s degree in Life Sciences from an accredited four-year college or university3+ years of experience in pharmaceutical or medical device advertising and promotional reviewIdeally 1–3 years of relevant regulatory experienceExperience working effectively with cross-functional groups, including Medical, Legal, and MarketingKnowledge and understanding of complex medical and scientific subject matterStrong oral communication and writing skillsUnderstanding of the U.S. pharmaceutical marketplaceFamiliarity with medical terminologyAbility to analyze data from different sources, draw conclusions, and choose appropriate courses of action or solutionsAbility to develop collaborative relationships and internal networksAbility to propose innovative solutionsAbility to use interpersonal styles and techniques to gain acceptance of ideas or plansUnquestionable ethics, professional integrity, and personal values consistent with Sanofi valuesAbility to balance projects with day-to-day duties and establish priorities and timelinesAbility to multitaskAbility to represent information and data accuratelyApplicants must be residents of the United States or Puerto RicoCore CompetenciesDemonstrates 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.Highest-signal resume keywordsRegulatory Strategies DevelopmentAdvertising and Promotional ReviewCross-Functional CollaborationRisk/Benefit AnalysisFDA Liaison ExperienceATS Optimization Keywords Hard SkillsRegulatory ComplianceAdvertising ReviewPromotional Material ReviewRisk Mitigation StrategiesData AnalysisLabeling ExpertiseProduct Launch StrategiesMedical TerminologyLife Cycle ManagementPharmaceutical KnowledgeSoft SkillsStrong Oral CommunicationWriting SkillsInterpersonal SkillsInnovative Problem SolvingProject ManagementIndustry KeywordsPharmaceutical IndustryMedical DeviceU.S. Pharmaceutical MarketplaceRegulatory AffairsPromotional ComplianceCross-Functional TeamsBrand ManagementCommercial MaterialsR&D GuidanceEthics and Integrity