About this opportunity
argenx SE lists this Regulatory Affairs Leader – US FDA Strategy (Remote) opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
argenx SE is seeking an Associate Director of Regulatory Affairs to shape the US regulatory strategy for a dynamic pipeline, including INDs and BLAs/NDAs. You will lead discussions with FDA, coordinate cross-functional teams, and drive timely regulatory submissions to support product launches and lifecycle management.
The role requires strong leadership, strategic thinking, and the ability to operate in a fast-paced biopharma environment, with remote work options in the United States.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.