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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. Reporting into Legal & Regulatory Compliance, you will shape submission strategies (INDs, NDAs, sNDAs), guide development teams, and ensure compliance with FDA and ex‑US requirements across the product lifecycle. You will interpret evolving regulations, lead health authority interactions, and provide risk-based advice to senior leaders. In Lundbeck’s collaborative, patient-focused culture, you will partner cross‑functionally to accelerate therapies for brain diseases while mentoring junior regulatory staff and driving continuous improvement.

Vacancy posted 9 days ago
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