Senior Director Global Regulatory Affairs

Job Description

Senior Director/Executive Director, Regulatory Affairs- Oncology

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Location: Remote from the US

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We are partnering with a global biotechnology company to hire a Director / Senior Director, Regulatory Affairs to lead the global registration strategy for a late-stage oncology program.

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This individual will lead the global marketing registration effort across the US, Europe, Japan and other key markets, with a particular emphasis on leading the US NDA submission through FDA approval. Regional Regulatory Leads will support the parallel ex-US applications.

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Key experience:

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• Proven experience leading an NDA and/or BLA submission, ideally through approval
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• Strong FDA interaction and late-stage regulatory strategy experience
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• Experience leading global marketing applications
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• Oncology experience required.
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• Strong cross-functional leadership within biotech/pharma
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This is an excellent opportunity to take overall regulatory leadership of a global program as it progresses through registration and commercialization.