[Hiring] Director Regulatory Advertising Promotional & Scientific Messaging @Lundbeck

Role Description

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.

• Bring hands-on US promotional regulatory expertise across healthcare professional (HCP) and direct-to-consumer (DTC) communications.
• Lead complex promotional reviews and strategy from the outset.
• Develop and execute regulatory advertising and promotion strategies across assigned brands and pipeline assets.
• Provide strategic guidance on product claims, scientific messaging, payer communications, and other promotional and external communications.
• Identify and assess regulatory risk, establish and communicate regulatory positions, and develop pragmatic solutions that support business objectives while maintaining regulatory compliance.

Qualifications

• Accredited Bachelor’s degree.
• 10+ years of R&D, regulatory or related experience within the pharmaceutical, biotechnology, and/or medical device industry, including 5+ years in the advertisement, promotional and scientific messaging area.
• Extensive, hands-on experience in US pharmaceutical advertising and promotion regulatory strategy and review of external communications for multiple audiences and channels.
• Demonstrated ability to lead complex promotional review and strategy, including interpretation and application of FDA promotional regulations and guidance and assessment of product claims and supporting scientific evidence across HCP and DTC.
• Strong knowledge of FDA requirements governing prescription drug and/or biologic advertising and promotion and experience navigating FDA interactions, including OPDP communications.
• Demonstrated ability to assess complex or novel regulatory issues, establish and clearly communicate regulatory positions, identify and articulate risk-based decisions, and develop pragmatic solutions that appropriately support compliance and business objectives.
• Strong understanding of scientific data and demonstrated ability to critically evaluate scientific evidence supporting promotional claims and communications.
• Demonstrated strategic leadership and ability to influence effectively at multiple levels, including brand and cross-functional teams as well as senior cross-functional stakeholders and leadership, in a highly matrixed environment.
• Experience supporting product launches and lifecycle management activities from an advertising and promotion regulatory perspective.
• Excellent negotiation, interpersonal, written, and oral communication skills.
• Demonstrated ability to manage multiple priorities, exercise sound independent judgment, and deliver high-quality work within established timelines.
• Ability to work independently while collaborating effectively within multidisciplinary, matrixed, and potentially global teams.

Requirements

• Accredited Bachelor’s degree in life sciences or an advanced degree in a scientific or healthcare-related field (PhD, PharmD, Master’s degree) and/or MBA.
• Experience supporting biologic and small-molecule products, including orphan and neuro-rare products.
• Experience leading FDA/OPDP interactions and promotional advisory comment processes.
• Experience leading cross-functional process improvement and development of advertising and promotion compliance capabilities.
• Experience providing leadership, coaching, or development to Regulatory Affairs colleagues and/or direct reports.
• Experience leveraging AI-enabled tools, modular content approaches, and other emerging digital capabilities to support compliant content development, review, governance, and lifecycle management in a regulated environment.
• Strong Preference to be based in Boston, MA area.

Benefits

• Salary Pay Range: $200,000 - $225,000.
• Eligibility for a 25% bonus target based on company and individual performance.
• Eligibility to participate in the company’s long-term incentive plan.
• Flexible paid time off (PTO).
• Health benefits to include Medical, Dental and Vision.
• Company match 401k.