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AstraZeneca plc

Strategic Regulatory Affairs Director, US

northern, KY

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About this opportunity

AstraZeneca plc lists this Strategic Regulatory Affairs Director, US opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Alexion seeks a Director of Regulatory Affairs US to lead regulatory strategies for assigned projects, ensuring successful registration and lifecycle management for innovative rare-disease products. You will drive submissions and collaborate with cross-functional teams, including external regulatory bodies, to shape program outcomes.

The role requires building strong relationships with FDA and global teams, guiding strategic regulatory advice across US, EU, and Canada, and ensuring alignment

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