Director, CMC Regulatory

Revolution Medicines•Redwood City, CA

3d•Hybrid

About The Position

Revolution Medicines is seeking a Director, CMC Regulatory to develop, drive, and execute CMC regulatory strategies for products progressing through clinical development and marketing authorization. The role combines strategic leadership with hands-on submission delivery, supporting global clinical trial applications, registration, commercial readiness, and lifecycle management. The Director will lead global CMC regulatory programs and submissions, participate in Health Authority interactions, collaborate with CMC and Quality teams on inspection readiness and regulatory commitments, and support post-approval CMC activities. The role also provides regulatory assessments for change controls, deviations, and investigations; coordinates regional requirements and approved CMC content with internal and external partners; and mentors team members while improving regulatory processes and submission standards.

Requirements

Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related scientific discipline.
At least 15 years of experience in pharmaceutical or biotechnology 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 the ability to manage complex technical content.
Experience leading global CMC-related submissions, including IND, IMPD/CTA, NDA, MAA, and post-approval variations.
Strong knowledge of U.S. and international GMP regulations and current industry practices, with the ability to interpret and apply requirements across the product lifecycle.
Strong project and team leadership capabilities, including prioritizing effectively, managing multiple complex programs, and fostering cross-functional collaboration.
Effective written and verbal communication and interpersonal skills.
Collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Nice To Haves

Advanced degree (MS or Ph.D.) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
Prior experience in oncology product commercialization.

Responsibilities

Serve as the CMC Regulatory program lead, developing and executing global CMC regulatory strategies from clinical development through marketing authorization and lifecycle management, aligned with program milestones and business objectives.
Lead preparation, review, and maintenance of scientifically sound, high-quality global CMC dossiers across development stages, ensuring compliance with applicable requirements and timely submissions.
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.
Support post-approval CMC regulatory activities, including assessing CMC changes, determining reporting requirements and supporting data needs, and developing and executing submission strategies.
Provide CMC regulatory assessments for change controls, deviations, and investigations, and track regulatory commitments and submission obligations.
Collaborate with Regulatory Affairs colleagues, technical subject-matter experts, and external partners to address regional requirements, support regulatory submissions, and maintain consistency of approved CMC content.
Mentor team members, guide regulatory resources, and contribute to improving CMC regulatory processes and submission standards.