Backed by GV.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field
- 10+ years of pharmaceutical / biotech drug development experience with 5 + years of experience of global CMC regulatory affairs
- Experience in CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.) (US, EU, APAC, LATAM)
- Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues
- Working experience and content knowledge in CMC development of NCEs (small molecules) or equivalent
- Demonstrated experience in effective collaboration with internal and external stakeholders
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.
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...
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