Lundbeck seeks a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. In this role, you will develop and execute regulatory plans across the product lifecycle, provide strategic guidance to R&D and Commercial teams, lead interactions with FDA and other health authorities, and ensure compliance with evolving regulations.
You will interpret regulatory requirements, prepare and review submissions (INDs, NDAs, sNDAs), and support labeling and risk management. Partnering closely with cross-functional teams, you will help shape development plans that advance Lundbeck’s mission to improve brain health worldwide in a collaborative, patient-focused culture.
Senior Manager Regulatory Strategy in oak park at Unknown Company
This position is listed as full time and onsite.