Director, Global CMC Regulatory – Post-Approval

revolutionmedicines; Redwood City (CA); On-site; USD 200,000 - 260,000; Full time

Job summary

Revolution Medicines seeks a Director, CMC Regulatory (post-approval) to lead global lifecycle regulatory strategies for Rasonque and other commercial products. You will drive post-approval submissions, ensure timely execution, and mentor junior team members in a fast-paced, innovative environment.

You will collaborate across PDM, RA, Quality, and Commercial functions, shaping regulatory strategy for site changes, analytical updates, and lifecycle activities while aligning with global

Qualifications

• Bachelor's degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.
• Minimum 15 years in pharmaceutical/biotech drug development, with at least 5 years in global CMC regulatory affairs for post-approval lifecycle.
• Strong knowledge of US and international regulations and ability to interpret requirements for commercial products.
• Strong leadership, prioritization, and cross-functional collaboration.
• Excellent written and verbal communication and interpersonal skills.
• Collaborative, high-energy team player in a fast-paced environment.

Responsibilities

• Serve as regulatory lead on assigned commercial programs/projects.
• Develop and implement post-approval regulatory strategies for site changes and lifecycle activities.
• Provide timely regulatory advice to support lifecycle planning and issue resolution.
• Lead preparation and submission of supplements, variations, annual reports, renewals.
• Perform regulatory assessments for change controls and deviations.
• Collaborate with cross-functional stakeholders to define global regulatory strategies and submissions.
• Monitor evolving guidance and simplify lifecycle processes or accelerate submissions.
• Support development programs to accomplish CMC-RA deliverables.
• Provide mentorship to junior CMC-RA colleagues and improve processes.

Skills

Regulatory leadership

Global CMC regulatory affairs

Project management

Cross-functional collaboration

Strategic thinking

Excellent written/verbal communication

Education

Bachelor's degree in Pharmaceutical Science

MS/PhD in Pharmaceutical Science

Job description

Revolution Medicines seeks a Director, CMC Regulatory (post-approval) to lead global lifecycle regulatory strategies for Rasonque and other commercial products. You will drive post-approval submissions, ensure timely execution, and mentor junior team members in a fast-paced, innovative environment.

You will collaborate across PDM, RA, Quality, and Commercial functions, shaping regulatory strategy for site changes, analytical updates, and lifecycle activities while aligning with global