USA remote
Associate Director, CMC Regulatory
About this role
Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.
Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients. 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 queries from HAs. Serve as the CMC regulatory representative on project teams and provide CMC regulatory support for the development of the investigational product(s) and marketed products and ensure applicable regulatory requirements are appropriately met.