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argenx SE

Remote Director of Regulatory Affairs (US)

northern, KY

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About this opportunity

argenx SE lists this Remote Director of Regulatory Affairs (US) opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

argënx SE is seeking a Director of Regulatory Affairs to lead the US regulatory strategy and act as the primary liaison with the FDA. The role covers pre- and post-approval activities across a growing pipeline, including INDs and BLAs/NDAs, with collaboration across medical, quality, and distribution functions.

You will drive regulatory submissions, monitor changes in the US landscape, and mentor a team in a fast-paced matrix environment. Remote work option in the United States is available.

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