Director, US Advertising and Promotion – Global Regulatory Affairs

Make decisions and provide strategic direction and oversight for assigned products, departmental activities, and direct reportsDevelop effective regulatory strategies regarding product promotion with the US A&P Therapeutic Area HeadProvide senior regulatory guidance and advice during issues management activitiesMonitor the regulatory environment and evaluate the business impact of new regulations, guidance documents, and enforcement trendsMentor and develop US A&P staffEstablish internal relationships with Commercial, R&D, Communications, Compliance, and Legal teamsEnsure alignment and consistency in US A&P policy application across assigned productsEstablish and maintain relationships with relevant FDA staffDevelop and implement regulatory strategies for marketed productsProvide input into global labeling strategies for marketed and pipeline productsLiaise with FDA regarding product promotion mattersPerform other duties as assignedRequirementsBachelor’s degree from an accredited four-year college or university; Science focus preferred, but not requiredExperience with in pharmaceutical or medical device Regulatory Affairs8+ years relevant regulatory experienceExperience in Advertising and Promotion in Regulatory requiredExperience dealing effectively with cross-functional groups, including Medical, Legal, and MarketingExtensive knowledge and understanding of complex medical and scientific subject matterUnderstanding of the U.S. pharmaceutical marketplace and familiarity with medical terminologySolid oral communication and writing skillsAbility to work well within cross-functional teamsAbility to manage product support projectsAbility to establish priorities and timelines and multi-task effectivelyUnquestionable ethics, professional integrity, and personal values consistent with Sanofi valuesCore CompetenciesDemonstrates extensive regulatory expertise in the pharmaceutical industry, particularly in Advertising and Promotion, while effectively managing cross-functional relationships and providing strategic oversight for product-related activities.Highest-signal resume keywordsRegulatory Affairs ExperienceAdvertising And Promotion ExpertiseCross-Functional CollaborationStrategic Direction And OversightFDA Liaison ExperienceHard SkillsRegulatory Strategy DevelopmentProduct Promotion RegulationLabeling Strategy InputRegulatory Environment MonitoringComplex Medical Subject Matter UnderstandingSoft SkillsSolid Oral CommunicationWriting SkillsProject ManagementPrioritization And Multi-TaskingMentoring And DevelopmentIndustry KeywordsPharmaceutical IndustryMedical Device Regulatory AffairsU.S. Pharmaceutical MarketplaceComplianceSanofi Values