Senior Manager, Regulatory Promotional Compliance – Scientific Messaging

Lundbeck

. Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities .

Posted 10/15/2026full-timeBoston • Massachusetts • United StatesSenior💰 $140,000 - $165,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in US Regulatory Affairs with a focus on advertising and promotion, ensuring compliance with FDA regulations and effective communication strategies. Capable of managing cross-functional collaborations and providing regulatory guidance for consumer-facing materials.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Advertising RequirementsDTC Promotional ReviewCross-Functional CollaborationAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceAdvertising ReviewPromotional Material AssessmentScientific Data InterpretationRisk CommunicationProject ManagementConsumer-Facing Claims AssessmentLifecycle ManagementRegulatory FrameworksDTC Campaign Development

Soft Skills

Excellent Communication SkillsOrganizational SkillsJudgmentProblem-SolvingAbility to Manage Competing Priorities

Tools & Technologies

Veeva PromoMatsRegulatory Content-Management Platforms

Certifications & Qualifications

Accredited Bachelor's DegreeAdvanced Degree in Scientific or Healthcare-Related Field

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryDTC CommunicationsHCP Promotional CommunicationsScientific ExchangeConsumer Communication ChannelsEmerging MediaOrphan ProductsNeuro-Rare Products

About the role

Key responsibilities & impact

Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities
Lead regulatory support primarily for DTC print, digital, social media, and other consumer-facing communications
Review and assess advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance, and internal policies
Represent Regulatory in Medical, Legal and Regulatory (MLR) reviews and other cross-functional forums
Identify and communicate regulatory risks, negotiate positions, propose compliant solutions, and escalate complex matters when appropriate
Provide early regulatory guidance on DTC concepts and communication strategies, including television, digital, social media, patient, and advocacy materials
Support HCP promotional communications and scientific exchange activities
Support product launch planning and lifecycle management, including launch material reviews and timeline coordination
Monitor the US advertising and promotion regulatory environment, FDA enforcement activities, guidance, and industry trends
Communicate regulatory implications to internal stakeholders
Improve advertising and promotional review processes through cross-functional collaboration
Share subject-matter expertise and best practices with Regulatory Affairs colleagues and cross-functional partners

Requirements

What you’ll need

Accredited bachelor’s degree
5+ years of experience in Regulatory Affairs, R&D, or a related area within the pharmaceutical or biotechnology industry, including 2 years of direct advertising and promotion experience or closely applicable Regulatory expertise
Working knowledge of US FDA advertising and promotion requirements
Demonstrated experience reviewing and interpreting customer communications
Hands-on experience with DTC promotional review
Ability to assess consumer-facing claims, presentations, and supporting scientific evidence
Demonstrated understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
Experience identifying and communicating regulatory risk and working cross-functionally in multidisciplinary and matrixed teams
Ability to independently manage assigned work and exercise sound judgment within established regulatory frameworks
Ability to recognize when escalation is appropriate
Strong attention to detail and organizational skills
Ability to manage multiple competing priorities and consistently meet deadlines
Excellent oral and written communication skills
Preferred: bachelor’s degree in life sciences, pharmacy, chemistry, or a related field, or advanced degree in a scientific or healthcare-related field
Preferred experience developing, reviewing, or launching DTC campaign materials, including television commercials, digital and social media, and/or patient and advocacy materials
Preferred experience with social media, emerging consumer communication channels, social influencers, or media pitching in the pharmaceutical environment
Preferred experience reviewing HCP promotional communications and/or scientific exchange materials
Preferred experience supporting biologic and small-molecule products, including orphan and neuro-rare products
Preferred experience with promotional review and regulatory content-management platforms, including Veeva PromoMats and/or related Veeva platforms
Ability to travel up to 20%; international travel may be required

Benefits

Comp & perks

15% 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