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Senior Manager Regulatory Strategy

Lundbeck

Lundbeck seeks a Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategies for innovative neuroscience therapies. You will drive product lifecycle planning, oversee submissions (INDs, NDAs, sNDAs), and interface with FDA and ex-U.S. health authorities. Partner with R&D, Clinical, Commercial, and Legal & Regulatory Compliance to ensure robust regulatory frameworks, risk assessments, and labeling strategies that align with patient and business needs. You will mentor junior staff and champion Lundbeck’s purpose-driven, patient-focused culture grounded in integrity, inclusion, and collaboration.

Vacancy posted 9 days ago
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