Backed by GV.
About the role
The Director, CMC Regulatory is responsible for developing, driving, and executing CMC regulatory strategies for products advancing through clinical development and marketing authorization. This role combines strategic leadership with hands-on submission delivery to support global clinical trial applications, registration, commercial readiness, and lifecycle management. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline
- Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience
- Deep expertise in CMC development for new chemical entities (NCEs), with proven ability to manage complex technical content
- Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, post approval variations, etc.)
- Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the entire product lifecycle
- Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration
More 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 Director, CMC Regulatory is responsible for developing, driving, and executing CMC regulatory strategies for products advancing through clinical development and marketing authorization. This role combines strategic leadership with hands-on submission delivery to support global clinical trial applications, registration, commercial readiness, and lifecycle management.
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