Remote Senior Manager, Regulatory Promotion & Messaging

Lonestar State College; Boston (MA); On-site; USD 140,000 - 165,000; Full time

Benefits offered by this job

Flexible PTO

Health benefits (Medical, Dental, V/V)

401k match

Job summary

Lundbeck, a global biopharmaceutical company focused on brain health, seeks a Senior Manager of Promotion Compliance and Scientific Messaging (US Regulatory Affairs) in Boston. You will lead regulatory advertising for DTC campaigns, guide cross-functional teams, and ensure FDA compliance across consumer materials.

You will coordinate with Medical, Legal and Regulatory review, assess promotional risks, and help shape launch concepts and lifecycle communications while advancing the company’s

Qualifications

• Accredited bachelor’s degree.
• 5+ years in Regulatory Affairs or related field within pharma/biotech.
• 2+ years in direct advertising and promotion or closely related regulatory expertise.
• Working knowledge of US FDA advertising and promotion requirements.
• Experience reviewing customer communications and promotional materials.
• Ability to independently manage assigned work and meet deadlines.

Responsibilities

• Serve as US Regulatory Affairs partner for advertising and promotion, focusing on DTC across print, digital and social media.
• Review materials for accuracy, labeling alignment, and FDA compliance.
• Represent regulatory perspective in MLR review and cross-functional forums, negotiating positions.
• Provide regulatory guidance early in DTC concept development and campaigns.
• Support HCP promotional communications and scientific exchange activities.
• Monitor FDA regulations, guidance, and industry trends and advise on implications.
• Contribute to process improvements in advertising review and cross-functional collaboration.

Skills

FDA advertising requirements

DTC promotional review

Cross-functional collaboration

Regulatory risk communication

Attention to detail

Regulatory writing

Education

Bachelor's degree

Advanced life sciences degree

Tools

Veeva PromoMats

Job description

Lundbeck, a global biopharmaceutical company focused on brain health, seeks a Senior Manager of Promotion Compliance and Scientific Messaging (US Regulatory Affairs) in Boston. You will lead regulatory advertising for DTC campaigns, guide cross-functional teams, and ensure FDA compliance across consumer materials.

You will coordinate with Medical, Legal and Regulatory review, assess promotional risks, and help shape launch concepts and lifecycle communications while advancing the company’s