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US Reg Affairs Lead | Regulatory Strategy & Execution

Alexion, Gaithersburg

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A leading biopharma company in Gaithersburg is seeking an Associate Regulatory Affairs Director. This role involves developing and implementing regulatory strategies for complex products serving patients with rare diseases. You will lead submissions, serve as the US Strategy Lead, and ensure compliance with regulatory policies. The ideal candidate has extensive experience in regulatory affairs, particularly with US drug development, and strong communication skills to liaise with FDA and cross-functional teams. Join us to help transform rare disease treatment.
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