Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies within our Legal & Regulatory Compliance team. You will develop and execute regulatory plans across development and marketed products, guide health authority interactions (FDA, EMA), and ensure compliant labeling, submissions, and lifecycle management. Partner cross functionally with Clinical, CMC, Safety, and Commercial to align on risk/benefit, influence portfolio decisions, and support inspections and audits. At Lundbeck, you'll work in a collaborative, patient focused culture with strong support for learning, development, and career growth. Responsibilities Lead U. S. and global regulatory strategies for CNS/neuroscience products across development and post approval stages Own planning, preparation, and submission of INDs, NDAs/BLAs, supplements, and agency meeting packages Serve as primary regulatory point of contact for FDA and other health authorities, managing meetings and responses Guide labeling strategy and ensure compliant prescribing information and promotional review support Provide regulatory input to clinical, safety, CMC, and commercial teams on study design and product changes Monitor regulatory intelligence and evolving guidelines to inform risk/benefit and portfolio decisions Support inspection and audit readiness, contributing to SOPs and best practices Mentor junior regulatory staff and foster strong cross functional partnerships Contribute to due diligence and business development assessments from a regulatory perspective Required Skills Regulatory strategy development FDA and EMA regulatory pathways

IND/NDA/BLA/MAA

preparation and submission Labeling development and compliance Regulatory intelligence and risk assessment Cross functional leadership and collaboration Neurology/CNS drug development knowledge Clinical trial regulatory requirements CMC regulatory requirements Inspection and audit readiness