Director Regulatory Advertising Promotion &… at Lundbeck · Massachus…

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!

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. 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.

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.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

• 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.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited Bachelor’s degree in life sciences or 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

TRAVEL

• Ability and willingness to travel domestically and internationally up to approximately 20%, as business needs require.
• If based remotely, additional travel will be required to Boston, MA to meet the needs of the role and the business

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $200,000 - $225,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.