Senior Manager Regulatory Strategy

Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. Based in Regulatory Compliance, you will drive regulatory planning from early development through post-approval, ensuring compliance with FDA/ICH requirements and alignment with company objectives. In this highly cross functional, patient focused role, you will guide submissions (INDs, NDAs, sNDAs), lead agency interactions, assess risk, and influence portfolio decisions.

You'll thrive in Lundbeck's collaborative, purpose driven culture with strong support for learning and career growth.

Responsibilities

• Lead U.
• S. and global regulatory strategies for neuroscience products from early development through post-approval.
• Plan, oversee, and QC key submissions (INDs, NDAs, s
• NDAs, amendments, supplements).
• Lead and prepare teams for FDA and other health authority meetings and interactions.
• Ensure compliance with FDA/ICH regulations and internal quality standards.
• Provide strategic regulatory input to clinical, CMC, safety, and commercial teams.
• Identify regulatory risks, develop mitigation plans, and influence portfolio decisions.
• Monitor and interpret regulatory intelligence and evolving guidelines.
• Coach and mentor junior regulatory staff and contribute to best practices.
• Support labeling strategy, promotional review, and lifecycle management activities.
• Represent Regulatory in cross-functional governance and project teams.

Required Skills

• Regulatory strategy development (U.
• S. and global)
• FDA/ICH regulations and guidance (IND, NDA, s
• NDA, post-marketing)
• CTD/e
• CTD submission planning and oversight
• Regulatory risk assessment and mitigation
• Cross-functional leadership and matrix collaboration
• Regulatory agency meeting planning and negotiation
• Clinical development and labeling strategy
• Neurology/CNS therapeutic area knowledge
• Project management and timeline/resource planning
• Regulatory intelligence and policy interpretation