Senior Manager, DTC Promotions & Regulatory Compliance

Lundbeck

Boston (MA)

On-site

USD 140,000 - 165,000

Full time

2 days ago
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Benefits offered by this job

Health benefits
401(k) match
Flexible PTO

Job summary

Lundbeck is seeking a Senior Manager, Promotion Compliance and Scientific Messaging in the US Regulatory Affairs group based in Boston. You will lead regulatory review of DTC campaigns, digital and social media, and consumer materials, ensuring alignment with FDA requirements and internal policies.

You will partner with Commercial, Medical, Legal, and cross-functional teams to provide pragmatic regulatory guidance, manage risk, and support launches and lifecycle activities.

Qualifications

  • Bachelor’s degree required.
  • 5+ years regulatory affairs experience in pharma/biotech.
  • Experience reviewing consumer promotions for FDA compliance.
  • Experience interpreting scientific data for regulatory needs.
  • Ability to work cross-functionally and manage deadlines.

Responsibilities

  • Partner on DTC print, digital and social media materials.
  • Review promotional materials for FDA compliance and labeling.
  • Represent regulatory perspective in cross-functional reviews (MLR).
  • Provide early regulatory guidance for DTC concepts.
  • Support launch and lifecycle planning with regulatory input.

Skills

FDA advertising regulations
DTC promotional review
Cross-functional collaboration
Regulatory strategy
Attention to detail
Oral and written communication

Education

Bachelor’s degree
Life sciences degree preferred

Tools

Veeva PromoMats

Job description

Lundbeck is seeking a Senior Manager, Promotion Compliance and Scientific Messaging in the US Regulatory Affairs group based in Boston. You will lead regulatory review of DTC campaigns, digital and social media, and consumer materials, ensuring alignment with FDA requirements and internal policies.

You will partner with Commercial, Medical, Legal, and cross-functional teams to provide pragmatic regulatory guidance, manage risk, and support launches and lifecycle activities.

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