Find & Apply For Regulatory Affairs Manager Jobs in Medinah, Illinois

Lundbeck is seeking a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for our neuroscience portfolio. In this role, you will design and execute regulatory pathways for development and commercialization, advise cross functional teams on FDA and global requirements, and drive submission planning for INDs, NDAs/sNDAs, and meeting packages. You will interpret evolving regulations, mitigate risk, and ensure inspection ready documentation. Partnering closely with R D, Clinical, Commercial, and Legal, you'll support labeling, lifecycle management, and compliance. At Lundbeck, you'll work in a purpose driven, collaborative culture focused on improving brain health worldwide. Responsibilities Lead U. S. and global regulatory strategies for neuroscience products across development and commercialization stages Design and execute regulatory pathways for INDs, NDAs/s NDAs, and key health authority interactions Prepare, review, and oversee high-quality regulatory submissions and meeting packages Provide regulatory guidance to R D, Clinical, Commercial, and Legal teams to ensure compliance Monitor and interpret evolving FDA and global regulations, guidance, and policies Identify regulatory risks and develop mitigation plans to support program success Support labeling strategy, product positioning, and lifecycle management activities Ensure inspection-ready documentation and contribute to audit/inspection preparation Represent Regulatory in cross-functional governance, project teams, and strategic discussions Mentor junior regulatory staff and contribute to process improvements and best practices Required Skills Regulatory strategy development FDA regulatory pathways (IND, NDA/s NDA) Global regulatory requirements (EMA/ICH) Regulatory submissions and documentation Labeling and lifecycle management Risk assessment and mitigation Cross-functional leadership Clinical development in CNS/neurology Regulatory intelligence and policy interpretation Excellent written and verbal communication