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Director, Precision Medicine And Digital Health - Global Regulatory Affairs
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Full-time
- Join Takeda as a Director, Precision Medicine and Digital Health where you will be responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support the development of biomarkers, diagnostic tests, devices, and digital health tools to enhance the value of our products across therapeutic areas.
- You will be responsible for overseeing the precision medicine and digital health efforts for assigned programs.
- Ensure global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
- Comprehensive understanding of biomarker strategies and implications for drug development.
- Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
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