Director US Regulatory Global Strategic Labelling

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

The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end‑to‑end (e2e) labelling process for development of new and/or revised labels, as well as strategic labelling development for pipeline assets. The candidate will champion the implementation of label as a driver process from early development through regulatory approval. They will be responsible for Global strategic Labelling (GSL) efforts to harmonize US and global processes for ensuring streamlined e2e labelling development and approval, as well as compliant lifecycle management.

They will serve as a reviewer for the Lundbeck Product Labelling Committee (LPLC) and related labelling compliance activities and may serve as liaison for cross‑functional governance bodies, such as Safety Committee/Board and LPLC. They will collaborate with cross‑functional team to support development, revision, maintenance and implementation of labelling while ensuring global and regional requirements and expectations are achieved in an optimal and compliant manner.

• Lead development of Global labelling strategy for new products and/or label revisions for existing active marketed products, by collaborating with cross‑functional teams during clinical development, regulatory submission and launch.
• Support Lundbeck Product Labeling Committee activities as LPLC reviewer, coordinating and collaborating with LPLC Chair/Deputy Chair, GSL Team and cross‑functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance.
• Provide competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post‑approval maintenance of global labelling activities, ensuring cross‑functional communication and execution per process.
• Partner with cross‑functional teams providing labeling expertise and regulatory knowledge to author and develop competitive and optimal target product labeling (TPL), CCDS, EU SmPC, USPI, CPM, Carton and Container and other labeling materials required for marketing registration that aligns with organizational business strategy and regulatory requirements.
• Ensure effective planning and execution of all cross‑functional labeling activities to maximize time‑bound high quality deliverables.
• Be responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross‑functional support.
• Liaise with CFTs to support labeling related information requests from regulatory bodies regarding label content and labeling change requests.
• Provide high‑level RA advice and identify regulatory requirements for labeling development and compliance to proactively advise on risk mitigation strategies for labeling submissions.
• Assess supporting information to support label language against regulatory requirements.
• Maintain awareness of global regulatory legislation and assess impact to active marketed, established marketed and development products/programs.
• Train, develop, and manage an effective cross‑functional regulatory affairs team on key labeling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, Safety, Clinical and International regulatory).

• Accredited Bachelor's Degree in life sciences.
• 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in…