Director Regulatory Promotional Compliance & Scientific Messaging

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

The Director, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) provides strategic regulatory leadership for advertising, promotion, scientific messaging, and external communications supporting the successful launch and lifecycle management of Lundbeck US products. The Director serves as a regulatory partner to Commercial, Medical, Legal, Market Access, Regulatory Affairs, and other cross-functional stakeholders, enabling effective and innovative product communications while ensuring compliance with FDA requirements, applicable guidance, and internal policies and procedures.

This role is expected to bring hands-on US promotional regulatory expertise across healthcare professional (HCP) and direct-to-consumer (DTC) communications and to lead complex promotional reviews and strategy from the outset. The Director leads the development and execution of regulatory advertising and promotion strategies across assigned brands and pipeline assets, providing strategic guidance on product claims, scientific messaging, payer communications, and other promotional and external communications.

The Director identifies and assesses regulatory risk, establishes and communicates regulatory positions, and develops pragmatic solutions that support business objectives while maintaining regulatory compliance.

• Serve as a US Regulatory Affairs advertising and promotion strategic partner for assigned brands, providing regulatory leadership across brand activities throughout launch and lifecycle management.
• Lead the regulatory review and assessment of claims, advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance documents, and internal policies and procedures.
• Represent and lead the Regulatory perspective in Medical, Legal and Regulatory (MLR) review and other cross-functional fora. Assess complex issues, articulate regulatory risk, negotiate positions, and develop compliant and commercially enabling solutions.
• Provide strategic regulatory guidance early in the development of scientific and promotional concepts and communication strategies, including HCP, DTC and payer communications, scientific exchange for pipeline projects, digital and social media, patient and advocacy materials, and other external communications.
• Provide regulatory promotional compliance leadership for launch planning and commercialization activities, including strategic review of launch concepts and materials that support successful execution of brand strategies.
• Provide strategic leadership for interactions with FDA/OPDP related to advertising and promotion, including advisory comments and other promotional regulatory matters, as appropriate.
• Partner closely with brand teams and with Commercial, Medical, Legal, Market Access, Corporate Communications, Regulatory Affairs, and other stakeholders to develop regulatory strategies that appropriately balance regulatory requirements, scientific evidence, patient needs, and business objectives.
• Build trusted relationships and influence effectively across organizational levels, from day-to-day brand and cross-functional teams to cross-functional stakeholders and…