Director, CMC Regulatory

Revolution Medicines•Redwood City, CA

1d•Remote

About The Position

The Director, CMC Regulatory (post-approval) provides strategic, hands-on, and operational leadership for global post-approval submissions and CMC activities for Rasonque and other commercial products in Revolution Medicines’ portfolio. The role leads complex global CMC lifecycle regulatory strategies across products and manufacturing sites, enabling timely execution of post-approval activities while improving submission efficiency and simplifying regulatory processes. The Director also supports the transition of commercial-stage programs to the CMC-RA post-approval function and, when needed, helps development programs deliver required regulatory work and submissions. The position requires strong knowledge of global regulations, guidelines, and regulatory precedent, as well as technical knowledge of development, technology transfers, and manufacturing processes.

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 biotech drug development.
At least 5 years of hands-on global CMC regulatory affairs experience supporting post-approval lifecycle management of small-molecule products, particularly solid oral dosage forms.
Strong knowledge of U.S. and international regulations and current industry practices, with demonstrated ability to interpret and apply requirements for commercial products.
Strong project and team leadership skills, including the ability to prioritize, manage multiple complex programs, and foster cross-functional collaboration.
Effective written and verbal communication and interpersonal skills.
Collaborative, high-energy approach; ability to thrive in a fast-paced, dynamic environment and embrace innovation and continuous improvement.

Nice To Haves

Advanced degree (MS or Ph.D.) in Pharmaceutical Science, Chemistry, Chemical Engineering, or a closely related field.
Experience with other modalities regulated by CDER, such as antibody therapeutics or ADCs.

Responsibilities

Serve as regulatory lead on assigned commercial programs and projects.
Develop and implement post-approval regulatory strategies, including filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
Provide timely, decisive regulatory advice to support product lifecycle planning and anticipate and resolve issues that could affect submission timelines.
Lead preparation, review, and execution of supplements, variations, annual reports, renewals, and related submissions.
Perform regulatory assessments of change controls and deviations, applying risk-based principles to categorize and prioritize post-approval changes.
Collaborate with stakeholders and peers in PDM, Regulatory Affairs, Quality, Commercial, and other functions, including local in-country colleagues, to define and execute global regulatory strategies and deliver high-quality, timely submissions.
Monitor emerging lifecycle-management guidance and apply it to submissions; identify opportunities to simplify lifecycle processes or accelerate submissions.
Support development programs as needed to complete CMC-RA deliverables and submissions.
Guide and mentor junior CMC-RA colleagues and contribute to improvements in CMC regulatory processes and submission standards.