Senior Manager, CMC Regulatory
About the position Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. This position is responsible for developing and implementing global CMC regulatory strategies. The role involves coordinating CMC regulatory activities to support the clinical development and eventual marketing approval of RevMed's pipeline compounds/products. The ideal candidate should have a strong understanding of regulatory requirements and be able to guide CMC teams throughout the drug development process. Responsibilities • Collaborate, and manage the CMC regulatory activities for global clinical trials, ensuring compliance with regulatory requirements across regions (FDA, EMA, APAC, etc.). • Collaborate with internal stakeholders to support the preparation of 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. • Assess changes to clinical trial materials or processes and prepare the necessary documents for regulatory amendments. • Identify and mitigate regulatory risks, manage CMC timelines and milestones, and ensure the timely submission of high-quality CMC dossiers to support clinical trials. • Provide updates to senior management on regulatory activities and submission progress. • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. • Represent department in cross-functional project teams. • Participate in the regulatory process initiatives and improvement activities. Requirements • BA/BS degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field. • 7+ years of pharmaceutical/biotech drug development experience in CMC development of NCEs/small molecules with 3+ years of CMC regulatory experience. • Experience in leading CMC related global submissions (IND, IMPD/CTA, NDA, MAA, etc.). • 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. • Demonstrated experience in effective collaboration with internal and external stakeholders. • Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment. • Effective written and verbal communication skills and good interpersonal skills. Nice-to-haves • Advanced degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field. • Hands on experience managing CMC submissions supporting global trials (US, EU, APAC, LATAM). • A collaborative team player who adapts quickly to new challenges with proven ability to thrive in a fast-paced environment, with a hands-on and result-driven approach and a strategic mindset. Benefits • Competitive cash compensation • Robust equity awards • Strong benefits • Significant learning and development opportunities Apply tot his job