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!

Remote/Commuter Opportunity - Open to candidates within the United States

SUMMARY: The Associate Director, Advertising & Promotion Compliance plays a critical role in ensures compliant and effective promotion and scientific messaging of Lundbeck’s U.S. pharmaceutical products throughout their lifecycle. The role provides regulatory strategic and promotional direction to support product launches, lifecycle management, and global product messaging as requested. By ensuring alignment with FDA regulations, corporate standards, and product labeling, the responsibilities include regulatory review, approval, and submission of promotional and medical materials, as well as maintaining productive relationships with internal partners and FDA/OPDP. The position also leads or supports regulatory training initiatives and serves as a resource on advertising and promotion regulations.

ESSENTIAL FUNCTIONS:

Provide regulatory reviews of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations, and global guidelines as appropriate. Manages, reviews and represents regulatory perspectives at promotional review meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, and delivers solution-oriented strategies. Manages/supports related FDA submission activities in compliance with current regulations.
Provide Regulatory strategic guidance on new commercial concepts, HCP/DTC commercial materials, scientific messaging content, market access materials, OPDP advisory processes, consistent with FDA label tactics, and health care economic communications, to identify and mitigate risk and ensure compliance.
Provide Regulatory promotional and scientific communication leadership on brand and life cycle management teams, process optimization efforts, development and collection of metrics, and further enhancement of cross functional interactions.
Provide internal and external training on departmental initiatives and for compliance purposes.
Monitor the external regulatory climate to inform internal customers of potential impact on long-term objectives; Represent Regulatory Affairs at cross-functional team meetings to communicate and implement agreed-upon regulatory strategy and compliance needs.
Develop and facilitate improvement efforts for internal promotional material review processes, through cross functional collaboration and leadership influence, to support necessary compliance enhancements and departmental efficiencies, including global process collaboration.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

Accredited bachelor’s degree
8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, biotech or medical device industry with at least 4 of those years within either advertising/promotion or Regulatory experience specific to neurology, migraine or biologics
Well versed in FDA Promotional Regulations and specifically experience in the review and interpretation of materials directed to healthcare professionals and direct-to-consumer audiences.
Experience in the review of technical content and assessment of product claim feasibility, in alignment with guidance associated with the communication of health care economic information and data analysis for consistent with label usage.
Expertise in navigating FDA interactions, including experience with FDA negotiations and/or OPDP communications.
Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
Proficiency in identifying regulatory risk and negotiating/resolving differences
Demonstrated leadership capabilities as leading by influence
Attention to detail and strong organizational skills with the ability to meet multiple deadlines
Demonstrated ability to work in a multi-disciplinary team
Excellent oral and written communication skills, including ability to articulate regulatory positions
Demonstrated experience leveraging digital tools, data, and AI-enabled solutions to improve processes, decision-making, or business outcomes; ability to translate emerging digital and AI capabilities into practical, value-creating applications.
High proficiency in MS Word, MS Excel and Adobe Acrobat
Proficient in Veeva or comparable document management system
High Proficiency in time management and demonstrated ability to work independently

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

Accredited bachelor's degree in science, Chemistry, Pharmacy or related subject study/experience
4 years of experience within either advertising/promotion or Regulatory experience specific to neurology or biologics
Knowledge in the Regulatory support of both biologics and small molecules
Degree in a Science Field (Ph.D., PharmD)
Experience in creation and launch of HCP / DTC campaign materials, including television commercials, social media, and/or patient and advocacy materials is beneficial.
Experience with disease awareness campaigns, scientific exchange and promotional actitivties within rare diseases, preferably in the neuro-rare space
Language - Strong Preference to be based in Deerfield, IL Office

TRAVEL

Willingness/Ability to travel ~10%+ domestically and/or internationally to business meetings and learning experiences.
If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business.

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $185,000 - $215,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

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