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:
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.
Responsibilities:
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Lead the preparation, review, and maintenance of scientifically sound, high-quality global CMC dossiers across all development stages, ensuring compliance with applicable regulatory requirements and timely submissions.
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Participate in CMC-related Health Authority interactions, including developing meeting strategies, preparing briefing documents, and responding to Agency queries. Collaborate with CMC and Quality teams to support inspection readiness and fulfill regulatory commitments.
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Support post-approval CMC regulatory activities, including assessing CMC changes, determining reporting requirements and supporting data needs, and developing and executing submission strategies.
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Provide CMC regulatory assessments for change controls, deviations, and investigations, and track regulatory commitments and submission obligations.
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Collaborate with Regulatory Affairs colleagues, technical SMEs, and external partners to address regional requirements, support regulatory submissions, and maintain consistency of approved CMC content.
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Mentor team members, provide guidance to regulatory resources, and contribute to improving CMC regulatory processes and submission standards.
Required Skills, Experience and Education:
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Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.
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Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.
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Deep expertise in CMC development for new chemical entities (NCEs), with proven ability to manage complex technical content.
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Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, post approval variations, etc.).
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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.
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Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.
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Effective written and verbal communication skills and interpersonal skills.
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A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.
Preferred Skills:
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Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.
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Prior experience in oncology product commercialization is a plus.
#LI-CT1 #LI-Hybrid
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