Senior Manager Regulatory Strategy

Role: Senior Manager, Regulatory Strategy (US RA) at Lundbeck, focusing on US regulatory development and approval of brain health therapeutics, supporting both investigational and marketed biologics and drugs. Responsibilities include providing regulatory review of submission documents, serving as US regulatory expert within cross-functional teams, liaising with FDA authorities, managing submissions, and monitoring US regulatory landscape to inform strategy. The role requires leading regulatory activities throughout product lifecycle, ensuring compliance with FDA regulations and guidances, and advising on clinical and marketing regulatory requirements. Qualifications: Bachelor’s degree, 7+ years in pharma/biotech with 5+ years in US Regulatory Affairs, demonstrated expertise in drug development, regulatory submissions, and risk assessment. Strong scientific data interpretation, communication skills, and ability to work independently and in matrix teams are essential. Preferred skills include advanced degrees in science, biologic development experience, and familiarity with CMC. High-value specifics: biologics and drugs in the neuroscience space, US development lifecycle, regulatory submission management, and interacting with FDA. Work setup: Remote within the US, with ~5% domestic travel, primarily to the Deerfield, IL office if remote.