Director Regulatory Affairs Alliance and Commercialization

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 opportunitiy - Open to candidates anywhere in the greater United States

SUMMARY:

The Director, US Regulatory Affairs Alliance and Commercialization, will oversee and lead regulatory affairs strategy for our alliance partnership products and commercialization efforts, requiring knowledge and expertise of regulations across scientific messaging, promotional compliance, global regulatory strategic labeling and regulatory strategy. This role will lead regulatory efforts for the successful development, approval, and lifecycle management of drug and biological alliance and Lundbeck products for the US and global markets, as well as providing support to the Lundbeck development portfolio. The Director will enable cross-functional team delivery, provide strategic regulatory guidance, and ensure compliance with applicable regulations and internal policies. In total, we are looking for someone with a broad regulatory background spanning the entire product value chain.

ESSENTIAL FUNCTIONS:

• Primary US regulatory point-of-contact for alliance product brands, as assigned, including managing cross-functional and multi-level governance and alignment meetings, including regulatory strategy, promotion, and labelling considerations.
• Ensure commercial enabling strategic partnership with alliance partners to accelerate brand success and foster Lundbeck connectivity into the alliance team matrix.
• Collaborate as the US  regulatory alliance product leader with global and other key stakeholders, influencing cross-functional partnership development teams and governance decisions.
• Oversee the assembly and creation of documentation to support investigational and marketing registration packages for the US FDA.
• Partner with alliance regulatory colleagues regarding submission activities, including, approval, and post-approval activities.
• Provide regulatory strategic guidance and identify requirements for clinical studies, marketing approval, product labelling and external scientific communication and Promotional activities.
• Lead regulatory engagement activities, including strategic, promotional, scientific, and labelling efforts, and provide regulatory guidance and promotional compliance directions for alliance portfolio and external communication materials, medical and scientific messaging, sales and marketing training, sample management, and product campaigns.
• Ensure compliance with US regulations, MLR processes, and internal policies on external communications, advertising, and promotion.
• Provide regulatory guidance on external corporate communications, patient advocacy, medical publications, and trial engagement materials.
• Provide directions to global labeling processes, including inform decisions on Target Product Label enabling optimal commercialization strategy.
• Support launch planning activities, including timeline development, strategic review of launch materials, and provide integrated communication.

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited bachelor’s degree.
• 10+ years R&D experience within a pharmaceutical, medical device, and/or biotech industry.
• 5+ years’ experience in Regulatory Affairs.
• Experience developing and maintaining alliance partnerships in regulatory activities within the US.
• Strong knowledge of US regulatory requirements and processes including understanding of regulatory interdependencies such as strategy, scientific messaging, promotional compliance and FDA labeling.
• Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams.
• Demonstrated alliance strategy leadership and motivation to successfully execute on regulatory strategies.
• Knowledge of development and registration timelines and requirements, to enable process management and compliance.
• Agile minded, seeker of innovative and creative solutions that comply