Associate Director, CMC Regulatory
Lyell Immunopharma
Location: Seattle, Washington, United States, United States
**Associate Director, CMC Regulatory at Lyell Immunopharma in Seattle, Washington, United States** **What you'll do** - Provide phase-appropriate guidance related to CMC regulatory requirements for cell therapy development - Lead CMC regulatory risk assessment and identify key issues throughout product lifecycle - Collaborate with CMC colleagues to develop content for INDs, IMPDs, and BLA/MAA submissions - Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents **What they're looking for** - Expertise in CMC regulatory requirements for cell therapy products - Experience with regulatory submissions and interactions with health authorities - Ability to manage regulatory projects and timelines - Skills in risk assessment and mitigation for regulatory issues **Details** - Location: Seattle, Washington, United States - Type: Not specified - Salary: Not specified
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