Executive Director Global Regulatory Affairs

Job Description

Senior Director/Executive Director RA - Remote from anywhere in the US

Regulatory Connect is partnering with a global biotechnology company to appoint an Executive Director of Regulatory Affairs who will lead the global registration strategy for a late-stage oncology program approaching submission.

This individual will have overall regulatory leadership of the program across the US, Europe, Japan and other key markets. A primary focus will be leading the US NDA through submission, FDA review and approval, supported by regional regulatory leads managing the parallel ex-US applications.

Key experience required:

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• Proven leadership of an NDA and/or BLA submission, ideally through FDA approval
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• Strong experience developing late-stage regulatory strategy and engaging directly with the FDA
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• Experience leading global marketing applications and coordinating regional submissions
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• Oncology development experience
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• Strong cross-functional leadership within a biotechnology or pharmaceutical environment
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This is a highly visible opportunity to take ownership of a global oncology program at a pivotal stage of development and lead it through registration, approval and commercialization.