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Healthcare Administration

US Reg Affairs Lead | Regulatory Strategy & Execution

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: Alexion
Full Time position
Listed on 2026-02-01
Job specializations:
  • Healthcare
    Healthcare Administration
Salary/Wage Range or Industry Benchmark: 200000 - 250000 USD Yearly USD 200000.00 250000.00 YEAR
Job Description & How to Apply Below
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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