Senior Manager, DTC Regulatory Advertising & Messaging

Lundbeck; Oregon; Hybrid; USD 140,000 - 165,000; Full time

Benefits offered by this job

15% bonus target

Medical, dental, vision coverage

401(k) match

Job summary

Lundbeck, a global biopharmaceutical company focused on brain health, seeks a Senior Manager, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) to lead regulatory advertising review for direct-to-consumer campaigns and cross-functional partnerships in the US.

The role emphasizes DTC communications, FDA regulatory guidance, and lifecycle management across products, with travel up to 20% and bonus eligibility.

Qualifications

• Accredited bachelor’s degree in a life science field or related area.
• 5+ years of Regulatory Affairs or related experience in pharma/biotech.
• 2 years of direct advertising and promotion experience or equivalent regulatory expertise.
• Working knowledge of US FDA advertising and promotion requirements.
• Hands-on experience with DTC promotional review and supporting evidence.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Serve as a US Regulatory Affairs partner for DTC and consumer channels.
• Review materials for FDA compliance and labeling consistency.
• Represent regulatory perspective in cross-functional reviews (MLR).
• Provide regulatory guidance early in DTC concept development.
• Monitor FDA advertising trends and communicate implications to stakeholders.

Skills

Regulatory affairs

DTC advertising review

FDA regulations

Cross-functional collaboration

Communication skills

Education

Bachelor's degree

Advanced degree in life sciences

Tools

Veeva PromoMats

Job description

Lundbeck, a global biopharmaceutical company focused on brain health, seeks a Senior Manager, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) to lead regulatory advertising review for direct-to-consumer campaigns and cross-functional partnerships in the US.

The role emphasizes DTC communications, FDA regulatory guidance, and lifecycle management across products, with travel up to 20% and bonus eligibility.