Director, CMC Regulatory

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 201,000 - 251,000; Full time

Job summary

Revolution Medicines, Inc. in Redwood City, CA, seeks a Director, CMC Regulatory to lead global CMC regulatory strategies and hands-on submission delivery across clinical development and commercial readiness.

You will manage global dossiers, interact with Health Authorities, and coordinate with cross-functional teams to ensure timely submissions and lifecycle management, while mentoring staff and driving continuous process improvements.

Qualifications

• Minimum 15 years in pharma/biotech drug development.
• At least 5 years in global CMC regulatory affairs.
• Experience leading global CMC submissions (IND, IMPD/CTA, NDA, MAA, post-approval variations).
• Strong knowledge of US and international GMP regulations.

Responsibilities

• Lead global CMC regulatory strategies from clinical development through marketing authorization.
• Prepare, review and maintain global CMC dossiers across development stages.
• Engage with Health Authorities and manage inspection readiness.
• Support post-approval CMC activities and regulatory commitments.
• Collaborate with Regulatory Affairs, SMEs and external partners to address regional requirements.
• Mentor team members and improve processes.

Skills

CMC regulatory

Global submissions

Regulatory strategy

Leadership

GMP knowledge

Education

Bachelor's degree in Pharmaceutical Science or related field

MS or PhD preferred

Job description

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.

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:

• Serve as the CMC Regulatory program lead to develop and execute global CMC regulatory strategies from clinical development through marketing authorization and lifecycle management, aligning regulatory activities and submission plans with program milestones and business objectives.
• 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.
• 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 SMEs, and external partners to address regional requirements, support regulatory submissions, and maintain consistency of approved CMC content.
• Mentor team members, provide guidance to regulatory resources, and contribute to improving CMC regulatory processes and submission standards.

Required Skills, Experience and Education:

• 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.
• Effective written and verbal communication skills and interpersonal skills.
• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

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

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [e-mail].

Base Pay Salary Range

$201,000 - $251,000 USD