Senior Director Regulatory Affairs, US Advertising and Promotion

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That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Senior Director manages a team of promotional regulatory professionals in the review and approval of U.S. promotional materials, ensuring high-quality and compliant execution. Demonstrates strong promotional regulatory expertise and provides strategic input to support promotional review activities for prescription drug products.

Ensures all promotional materials comply with applicable laws, regulations, and regulatory agency guidance, including FDA requirements, and supports the development of compliant and effective promotional strategies.

Provides oversight and guidance across multiple therapeutic areas, with the ability to assess and make sound regulatory decisions on complex promotional regulatory issues. Drives alignment and facilitates effective collaboration with U.S. Marketing leadership to support business objectives while maintaining regulatory compliance.

• Build, lead, and mentor a high-performing U.S. regulatory Ad/Promo team.
• Shape and advance regulatory strategy and solutions governing U.S. advertising and promotion to enable sustained compliance with evolving regulatory requirements and alignment with Company policy and business priorities
• Manage interactions and correspondence with FDA’s promotional review divisions (OPDP and APLB), including addressing complex questions and overseeing submissions for advisory comment.
• 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 compliance
• Provide 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…