Director, CMC Regulatory Strategy – Oncology

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, 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.