Director, Regulatory Promotional Compliance – Scientific Messaging

Lundbeck

. Serve as a US Regulatory Affairs advertising and promotion strategic partner for assigned brands throughout launch and lifecycle management .

Posted 10/15/2026full-timeBoston • Massachusetts • United StatesLead💰 $200,000 - $225,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in US pharmaceutical advertising and promotion regulatory strategy, with a strong ability to lead complex promotional reviews and navigate FDA interactions. Proven track record in providing strategic regulatory guidance and building relationships across multidisciplinary teams.

Highest-signal resume keywords

US Pharmaceutical Advertising And Promotion Regulatory StrategyFDA Promotional Regulations And GuidanceRegulatory Review And AssessmentStrategic Leadership And InfluenceComplex Issue Assessment And Risk Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsPromotional Compliance LeadershipScientific Evidence EvaluationProduct Launch SupportRegulatory Risk AssessmentNegotiation SkillsAdvertising And Promotion StrategyFDA Interaction ManagementRegulatory Position CommunicationLifecycle Management Activities

Soft Skills

Interpersonal SkillsWritten Communication SkillsOral Communication SkillsIndependent JudgmentCollaboration Skills

Certifications & Qualifications

Accredited Bachelor’s Degree

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryMedical Device IndustryFDAOPDPHCPDTCPayer CommunicationsDigital And Social MediaRegulatory Environment Monitoring

About the role

Key responsibilities & impact

Serve as a US Regulatory Affairs advertising and promotion strategic partner for assigned brands throughout launch and lifecycle management
Lead regulatory review and assessment of claims, advertising, and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance, and internal policies
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 and commercially enabling solutions
Provide strategic regulatory guidance for HCP, DTC, payer, scientific exchange, digital and social media, patient and advocacy, and other external communications
Provide regulatory promotional compliance leadership for launch planning and commercialization activities
Lead interactions with FDA/OPDP related to advertising and promotion, including advisory comments and other promotional regulatory matters
Partner with Commercial, Medical, Legal, Market Access, Corporate Communications, Regulatory Affairs, and other stakeholders to develop regulatory strategies
Build trusted relationships and communicate regulatory positions and recommendations across organizational levels
Monitor the evolving US advertising and promotion regulatory environment and translate developments into actionable recommendations
Provide regulatory leadership, coaching, and subject-matter expertise to colleagues and cross-functional stakeholders

Requirements

What you’ll need

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
Strong understanding of scientific data and ability to critically evaluate scientific evidence supporting promotional claims and communications
Demonstrated strategic leadership and ability to influence effectively at multiple levels 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
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
Ability and willingness to travel domestically and internationally up to approximately 20%
Strong Preference to be based in Boston, MA area

Benefits

Comp & perks

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)
Medical, Dental and Vision health benefits
Company match 401k
Reasonable accommodations during the employment application process
Equal employment opportunity workplace