Associate Director, CMC Regulatory

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About this role

Associate Director, CMC Regulatory Redwood City, California, United States Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: As part of our expanding organization, we seek a strategic and hands-on Associate Director, CMC Regulatory who will be responsible for executing CMC regulatory strategies to support clinical development, marketing authorizations, and lifecycle management of RevMed's pipeline compounds/products. This role involves coordinating and preparing CMC sections of regulatory submissions to support RevMed's global clinical trials, market applications and post approval changes. The ideal candidate should have a strong understanding of global regulatory requirements during different phases of development, and be able to provide regulatory guidance to the CMC teams accordingly. Responsibilities: - Develop, lead, and implement global CMC regulatory strategies to support the clinical development, registration, and post-marketing activities. - Lead the preparation and maintenance of the CMC / quality sections for regulatory submissions including initial submission of IND, IMPD/CTA, NDA, MAA and amendments to Health Authorities (HAs), and preparation of responses to

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