Remote Director, Regulatory Promotion & Messaging

Lundbeck LLC; Boston (MA); On-site; USD 200,000 - 225,000; Full time

Job summary

Lundbeck seeks a Director for Promotion Compliance and Scientific Messaging in US Regulatory Affairs to drive advertising, promotion, and external communications with FDA-aligned strategy from launch through lifecycle.

The role partners with Commercial, Medical, Legal, Market Access, and Regulatory Affairs to shape compliant, scientifically-supported messaging across HCP, DTC, and payer channels. Strong leadership is essential.

Qualifications

• Accredited Bachelor’s degree.
• 10+ years in R&D, regulatory or related areas with 5+ years in advertising, promotional and scientific messaging.
• Hands-on experience in US pharmaceutical advertising and promotion regulatory strategy & review.
• Ability to lead complex promotional reviews and interpret FDA guidance.
• Strong knowledge of FDA requirements for prescription products and OPDP interactions.
• Ability to articulate risk-based regulatory decisions in a matrixed environment.
• Strong scientific literacy to evaluate evidence supporting promotional claims.
• Proven leadership in cross-functional teams and launches.

Responsibilities

• Lead US advertising and promotion regulatory strategy for assigned brands.
• Oversee regulatory review of claims, advertising, and materials for FDA compliance.
• Represent Regulatory in Medical, Legal and Regulatory reviews and cross-functional fora.
• Provide early regulatory guidance on scientific and promotional concepts.
• Lead regulatory input for HCP, DTC and payer communications.
• Guide launch planning and promotional material review for brands.
• Engage with FDA/OPDP on advisory comments and related matters.
• Develop strategies balancing regulatory requirements with business needs.
• Foster cross-functional collaboration with brand teams and stakeholders.
• Monitor evolving regulatory environment and translate into actionable actions.
• Provide coaching and subject-matter expertise to Regulatory Affairs colleagues.

Skills

Regulatory leadership

FDA knowledge

Promotion compliance

Cross-functional collaboration

Strategic thinking

Negotiation

Communication skills

Launch experience

Education

Bachelor’s degree

Advanced degree in life sciences or healthcare

MBA

Job description

Lundbeck seeks a Director for Promotion Compliance and Scientific Messaging in US Regulatory Affairs to drive advertising, promotion, and external communications with FDA-aligned strategy from launch through lifecycle.

The role partners with Commercial, Medical, Legal, Market Access, and Regulatory Affairs to shape compliant, scientifically-supported messaging across HCP, DTC, and payer channels. Strong leadership is essential.