Director US Regulatory Global Strategic Labelling

Lundbeck is seeking a Director, US Regulatory Global Strategic Labelling to lead US labeling strategy across our neuroscience portfolio. In this pivotal role, you will own end-to-end US labeling development, negotiation, and maintenance, ensuring compliance with FDA regulations and alignment with global strategy. You will chair cross functional labeling teams, drive labeling content for submissions, safety updates, and promotional materials, and partner closely with Regulatory Affairs, Legal, Safety, Medical, and Commercial. This role offers high visibility, influence on global strategy, and the opportunity to advance treatments for brain diseases in a purpose driven culture.

Responsibilities

• Lead US regulatory labeling strategy for assigned products across their lifecycle
• Own development, negotiation, and maintenance of US labeling (USPI, SPL, Med Guides, cartons)
• Chair cross-functional labeling teams and ensure alignment with global labeling governance
• Drive labeling content for initial and supplemental submissions, safety updates, and CMC changes
• Ensure labeling compliance with FDA, ICH, and internal quality standards
• Partner with Legal, Safety, Medical, and Commercial to review and approve labeling text
• Monitor regulatory landscape and interpret new FDA and global labeling guidance
• Support labeling aspects of inspections, audits, and health authority interactions
• Mentor and develop labeling and regulatory team members
• Contribute to global labeling strategy to align US needs with international markets

Required Skills

• US FDA labeling regulations and guidance
• Global labeling strategy development
• Regulatory submissions (NDA/BLA/s
• NDAs/s
• BLAs)
• Cross-functional leadership and governance
• Core Data Sheet/USPI/Medication Guide development
• Risk management and safety labeling (RMP/REMS)
• Labeling change control and lifecycle management
• Regulatory writing and documentation
• Labeling review for promotional materials
• Project and stakeholder management