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Lundbeck

Senior Manager, Regulatory Advertising, Promotion & Scientific Messaging

Lundbeck

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

Posted 10/26/2026full-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 while effectively managing cross-functional communication and collaboration. Possesses strong analytical skills to assess regulatory risks and develop compliant strategies for consumer-facing communications.

Highest-signal resume keywords
Regulatory Affairs ExperienceFDA Advertising And Promotion RequirementsDTC Promotional ReviewCross-Functional CollaborationRegulatory Risk Assessment

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Regulatory AffairsAdvertising And PromotionFDA CompliancePromotional Material ReviewScientific Data InterpretationConsumer-Facing Claims AssessmentLifecycle ManagementLaunch PlanningRegulatory Risk CommunicationDTC Concepts Guidance
Soft Skills
Attention To DetailOrganizational SkillsOral CommunicationWritten CommunicationJudgment
Certifications & Qualifications
Accredited Bachelor's Degree
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryMedical Review ForumsConsumer CommunicationsAdvertising Review Processes

About the role

Key responsibilities & impact
  • Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities
  • Lead regulatory support for DTC print, digital, social media, and other consumer-facing communications
  • Review promotional materials for accuracy, consistency with approved labeling, and FDA compliance
  • Represent Regulatory Affairs in Medical, Legal and Regulatory review forums
  • Identify regulatory risks, negotiate positions, and propose compliant solutions
  • Provide guidance on DTC concepts and communication strategies, including television, digital, social, patient, and advocacy campaigns
  • Support HCP promotional communications and scientific exchange activities
  • Support launch planning and lifecycle management, including launch material reviews and timeline coordination
  • Monitor FDA regulations, guidance, enforcement activities, and industry trends
  • Contribute to improvements in advertising and promotional review processes
  • Share subject-matter expertise and best practices with Regulatory Affairs 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
  • 2 years of direct advertising and promotion experience or closely applicable Regulatory expertise
  • Working knowledge of US FDA advertising and promotion requirements
  • Experience reviewing and interpreting customer communications
  • Hands-on experience with DTC promotional review
  • Ability to assess consumer-facing claims, presentations, and supporting scientific evidence
  • Understanding of scientific data and promotional regulations relating to drugs and/or biologics
  • Experience identifying and communicating regulatory risk
  • Ability to work cross-functionally in multidisciplinary and matrixed teams
  • Ability to independently manage assigned work and exercise sound judgment
  • Strong attention to detail and organizational skills
  • Excellent oral and written communication skills
  • 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