Senior Manager Regulatory Promotional Compliance & Scientific Messaging

Senior Manager Regulatory Promotional Compliance & Scientific Messaging

Requisition

Location:

Boston, MA, US

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases.

Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

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* SUMMARY:

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* The Senior Manager, Promotion Compliance and Scientific Messaging (US Regulatory Affairs) provides regulatory advertising and promotional support for the successful launch and lifecycle management of Lundbeck US products. The role serves as a regulatory partner to Commercial, Medical, Legal, and other cross-functional stakeholders, helping enable effective product communications while ensuring compliance with FDA requirements, applicable guidance, and internal policies and procedures.

The Senior Manager will have a primary focus on direct-to-consumer (DTC) communications, including consumer campaigns, digital and social media, patient and advocacy materials, and related scientific messaging. The role manages assigned promotional review activities within this remit, providing regulatory guidance on DTC concepts and claims, identifying and communicating regulatory risk, and developing practical solutions in partnership with cross-functional teams, and escalating novel, highly complex, and precedent-setting matters as appropriate.

The Senior Manager will also support HCP communications and scientific exchange activities, contributing across the broader promotional compliance portfolio when needed. In addition, the Senior Manager will contribute to regulatory launch and lifecycle activities, FDA promotional submissions, regulatory intelligence,  and continuous improvement of advertising and promotion review processes, escalating novel, highly complex, and precedent-setting matters as appropriate.

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* ESSENTIAL FUNCTIONS:

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* + Serve as a US Regulatory Affairs advertising and promotion partner for assigned brands and activities, with primary responsibility for DTC print, digital and social media communications and other consumer-facing channels.

+ Review and assess assigned advertising and promotional materials for accuracy, consistency with approved product labeling, and compliance with FDA regulations, guidance documents, and internal policies and procedures.

+ Represent the Regulatory perspective in Medical, Legal and Regulatory (MLR) review and other cross-functional forums for assigned materials. Identify and communicate regulatory risks, negotiate positions, and propose practical, compliant solutions, escalating where appropriate.

+ Provide regulatory guidance early in the development of DTC concepts and communication strategies, including television and other consumer campaigns, digital and social media, patient and advocacy materials, and related scientific messaging.

+ Support HCP promotional communications and scientific exchange activities as part of the broader Promotion Compliance and Scientific Messaging portfolio.

+ Support launch planning and lifecycle management activities, including review of launch concepts and materials, timeline coordination, and communication of regulatory considerations to cross-functional partners.

+ Monitor the evolving US advertising and promotion regulatory environment, including FDA regulations, guidance, enforcement activities, and relevant industry trends, and communicate potential implications to internal stakeholders.

+ Contribute to continuous improvement of advertising and promotional review processes through cross-functional collaboration, supporting compliance, efficiency, decision-making, and quality.

+ Contribute subject-matter expertise and share best practices with Regulatory Affairs colleagues and cross-functional partners.

** REQUIRED EDUCATION,

EXPERIENCE AND SKILLS:

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* + Accredited bachelor's degree.

+ 5+ years of experience in Regulatory Affairs, R&D, or a related area within the pharmaceutical or biotechnology industry, including 2 years of direct advertising and promotion experience or closely applicable Regulatory expertise.

+ Working knowledge of US FDA advertising and promotion requirements, with demonstrated experience reviewing and interpreting…