Global Regulatory Strategy Director — Oncology
Exelixis Inc
Exelixis Inc. seeks an Executive Director, Regulatory Affairs to oversee global regulatory activities from pre-IND to BLA/NDA and post- approval, developing strategies across clinical, non-clinical and CMC disciplines. This role leads the regulatory program team, ensuring timely, high-quality submissions and effective agency interactions, with emphasis on oncology drug development and successful registrations in multiple markets. #J-18808-Ljbffr Exelixis Inc
$195k - $277.5k
SUMMARY/JOB PURPOSE: Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions...SuggestedFull timeWork at officeLocal areaFlexible hours- Exelixis, Inc. in Alameda, CA is seeking an Assoc Regulatory Affairs Strategy Director (Oncology) to lead global regulatory strategies, ensure timely submissions, and guide study teams. The role requires senior-level expertise in regulatory affairs and collaboration with...Suggested
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SUMMARY/JOB PURPOSE: Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid...Full timeContract workWork at officeLocal areaFlexible hours- Exelixis Inc. seeks a senior leader to drive recruitment and retention governance for informed consent across global clinical trials. You will align policy with external regulations and collaborate with CROs, vendors, and site teams to meet enrollment goals. You will guide...
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SUMMARY/JOB PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission... .../he utilizes in-depth knowledge of global regulatory submission requirements and... ..., risks, or impact due to changes in strategy and/or timelines are assessed quickly...Full timeWork at officeLocal areaFlexible hours
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