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Senior Director, CMC Regulatory Affairs
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$220,000 - $280,000 a year
Full-time
- Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
- Allogene is seeking a Senior Director, CMC Regulatory Affairs to provide support for products under development and lead CMC product strategy and provide regulatory direction to quality, manufacturing/tech ops and supply chain teams.
- Reporting to the Head of Regulatory Affairs, this individual will be responsible for assuring the CMC regulatory strategy is aligned with Health Authority requirements and regulatory submissions are on time and high quality.
- As a member of the CMC project teams, provide strategic CMC regulatory leadership support for multiple innovative Allogeneic CAR T programs.
- Maintain responsibility for all CMC Regulatory timelines.
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