Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Gilead Sciences · Foster City, CA
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Role summary
Senior Manager leading CMC regulatory strategy for device and combination product programs at Gilead. Responsibilities include developing global regulatory strategies, preparing submissions for clinical and marketing applications, partnering with development teams on control strategy and design elements, and managing health authority interactions. Position requires expertise in device regulations and lifecycle management across development, registration, and post-approval phases.
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