Director Regulatory Promotional Compliance & Scientific Messaging

Lundbeck•Boston, MA

10d•$200,000 - $225,000

About The Position

The Director, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) provides strategic regulatory leadership for advertising, promotion, scientific messaging, and external communications supporting the launch and lifecycle management of Lundbeck US products. The Director partners with Commercial, Medical, Legal, Market Access, Regulatory Affairs, and other stakeholders to enable effective product communications while ensuring compliance with FDA requirements, applicable guidance, and internal policies and procedures. The role requires hands-on US promotional regulatory expertise across healthcare professional (HCP) and direct-to-consumer (DTC) communications, and leadership of complex promotional reviews and strategies. The Director develops and executes regulatory advertising and promotion strategies for assigned brands and pipeline assets, advising on product claims, scientific messaging, payer communications, and other promotional and external communications. The position identifies and assesses regulatory risk, establishes and communicates regulatory positions, and develops pragmatic solutions that support business objectives while maintaining compliance. The position includes domestic and international travel of up to approximately 20% as business needs require. Remote employees will have additional travel to Boston, MA. The role has a national salary range of $200,000–$225,000, eligibility for a 25% performance-based bonus target, and eligibility to participate in the company’s long-term incentive plan.

Requirements

Accredited bachelor’s degree.
At least 10 years of R&D, regulatory, or related experience in the pharmaceutical, biotechnology, and/or medical device industry, including at least 5 years in advertising, promotion, and scientific messaging.
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 interpreting and applying FDA promotional regulations and guidance and assessing product claims and supporting scientific evidence across HCP and DTC communications.
Strong knowledge of FDA requirements governing prescription drug and/or biologic advertising and promotion, and experience navigating FDA interactions, including OPDP communications.
Ability to assess complex or novel regulatory issues, establish and communicate regulatory positions, identify and articulate risk-based decisions, and develop pragmatic solutions that support compliance and business objectives.
Strong understanding of scientific data and ability to critically evaluate evidence supporting promotional claims and communications.
Strategic leadership and ability to influence at multiple levels, including brand and cross-functional teams and senior stakeholders, in a highly matrixed environment.
Experience supporting product launches and lifecycle management from an advertising and promotion regulatory perspective.
Excellent negotiation, interpersonal, written, and oral communication skills.
Ability to manage multiple priorities, exercise sound independent judgment, and deliver high-quality work within established timelines.
Ability to work independently and collaborate effectively with multidisciplinary, matrixed, and potentially global teams.
Ability and willingness to travel domestically and internationally up to approximately 20% as business needs require; remote-based employees will have additional travel to Boston, MA.

Nice To Haves

Accredited bachelor’s degree in life sciences or an advanced degree in a scientific or healthcare-related field (PhD, PharmD, or master’s degree) and/or an 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 developing 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 for compliant content development, review, governance, and lifecycle management in a regulated environment.
Strong preference for candidates based in the Boston, MA area.

Responsibilities

Serve as the US Regulatory Affairs advertising and promotion strategic partner for assigned brands throughout launch and lifecycle management.
Lead regulatory review and assessment of claims and advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance, and internal policies and procedures.
Represent and lead the Regulatory perspective in Medical, Legal and Regulatory (MLR) review and other cross-functional forums; assess complex issues, articulate regulatory risk, negotiate positions, and develop compliant, commercially enabling solutions.
Provide strategic regulatory guidance early in the development of scientific and promotional concepts and communication strategies, including HCP, DTC, payer, pipeline scientific exchange, digital and social media, patient and advocacy materials, and other external communications.
Provide regulatory promotional compliance leadership for launch planning and commercialization, including strategic review of launch concepts and materials.
Lead strategic interactions with FDA/OPDP related to advertising and promotion, including advisory comments and other promotional regulatory matters, as appropriate.
Partner with brand teams and Commercial, Medical, Legal, Market Access, Corporate Communications, Regulatory Affairs, and other stakeholders to develop regulatory strategies that balance regulatory requirements, scientific evidence, patient needs, and business objectives.
Build trusted relationships and influence across organizational levels, communicating regulatory positions and recommendations clearly and consistently.
Monitor changes in the US advertising and promotion regulatory environment, including FDA regulations, guidance, enforcement activities, and industry trends, and translate developments into actionable recommendations.
Provide regulatory leadership, coaching, and subject-matter expertise to colleagues and cross-functional stakeholders, including through influence across matrixed teams.