Director Regulatory Advertising Promotional & Scientific Messaging
Lundbeck
Summary
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.
Job description
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.
Essential Functions
- 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 leadership, ensuring clear and consistent communication of regulatory positions and recommendations.
- Monitor the evolving US advertising and promotion regulatory environment, including FDA regulations, guidance, enforcement activities, and industry trends, and translate developments into actionable recommendations for business and regulatory stakeholders.
- Provide regulatory leadership, coaching, and subject-matter expertise to colleagues and cross-functional stakeholders, including leadership through influence across matrixed teams.
Requirements
- Accredited Bachelor’s degree
- 10+ years of R&D, regulatory or related experience within the pharmaceutical, biotechnology, and/or medical device industry
- 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
Benefits
- Flexible PTO
- Medical, Dental & Vision
- 401(k) Matching
- 25% Bonus Target
- Long-Term Incentive Plan
Company overview
Lundbeck is a global pharmaceutical company specializing exclusively in brain diseases, with over 70 years of neuroscience expertise. Founded in 1915 in Copenhagen, Denmark, the company has established itself as one of the world's leading innovators in treatments for central nervous system disorders. Lundbeck focuses on developing and commercializing therapies for conditions including depression, schizophrenia, Alzheimer's disease, Parkinson's disease, and migraine. With approximately 5,000+ employees worldwide and operations in more than 50 countries, the company maintains production facilities in Denmark, France, and Italy, with research centers in Denmark and the United States. Lundbeck's portfolio includes some of the world's most widely prescribed therapies for brain diseases, reaching over 7 million people daily. The company is publicly traded on Nasdaq Copenhagen, with the Lundbeck Foundation holding approximately 70% ownership. Lundbeck's commitment to neuroscience research and patient-centered innovation has positioned it as a key player in addressing the complex challenges of brain health globally.