Senior Director Regulatory Affairs, US Advertising and Promotion

Work Your Magic with us! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Shape regulatory strategy and provide expert oversight on proposed product claims for assets in development, ensuring scientifically sound and compliant messaging, and guiding (or oversees) the development of Important Safety Information (ISI) and Brief Summary documents, as appropriate.Establish and advance the strategic framework for advertising and promotion processes and SOPs, driving continuous improvement to enhance operational efficiency and ensure sustained regulatory complianceProvide strategic leadership in monitoring and interpreting regulatory developments, guidance, and enforcement trends, and ensure timely dissemination of actionable insights to Regulatory Affairs teams, review committees, and cross-functional partners to inform compliant business decisions.Lead the evaluation of emerging regulatory trends, guidance, and enforcement activities, and proactively shapes organizational understanding by advising Regulatory Affairs, review leadership, and cross-functional stakeholders on regulatory and policy implications within OPDP and APLB, and the broader regulatory landscape to support informed, compliant decision-making.Drive strategic integration between labeling and promotional regulatory activities by partnering with the Regulatory Affairs labeling group to assess the impact of package insert changes on product promotion and overall communication strategy.Negotiate and influence business unit decisions by driving consensus with review and commercial leadership.Oversee and supports the execution of company-wide training on regulatory requirements for product promotion, ensuring ongoing skills development and compliance awareness across the organization. Perform additional responsibilities as needed.Provide strategic regulatory leadership as a core member of cross-functional promotional review teams, influencing key stakeholders across marketing, legal, medical, and regulatory functions to achieve compliant and business-aligned promotional outcomes.Drive the development and evolution of advertising and promotion processes and procedures, shaping best practices and governance to support compliant and effective promotional activities across the organization.Lead cross-functional collaboration with Quality on internal audits and CAPA activities, ensuring regulatory alignment and driving effective resolution of compliance findings.Who You Are Minimum 10 or more years of pharmaceutical industry or related experience with an emphasis in regulatory or scientific disciplines, with a minimum of seven years of direct experience as the primary reviewer of advertising and promotional materials.Ability to provide supervision and support across multiple therapeutic areas.Demonstrated ability to make day-to-day regulatory decisions for escalations.