Director, CMC Regulatory

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 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.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor-all in service of patients.

The Opportunity

The Director, CMC Regulatory (post-approval) is responsible for providing strategic, hands-on and operational leadership for global post-approval submissions and CMC activities for Rasonque and other commercial products in RevMed's portfolio. This role will lead complex global CMC lifecycle regulatory strategies across products and manufacturing sites, enabling timely execution of post-approval regulatory activities while improving submission efficiency, and simplifying regulatory processes. The individual will also support the successful transition of commercial-stage programs to the CMC-RA post-approval function. When required, the individual will also support development programs working with CMC-RA colleagues to accomplish the required regulatory deliverables and submissions.

This is accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence, coupled with a strong technical knowledge of development, technology transfers and manufacturing processes.

Responsibilities:

• Serve as regulatory lead on assigned commercial programs/projects.
• Develop and implement post-approval regulatory strategies for assigned products defining filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
• Provide high-quality, timely, and decisive regulatory advice to allow project teams to make well-informed decisions on product lifecycle planning; anticipate and resolve technical or operational issues that could impact submission timelines.
• Lead preparation, review, and execution of supplements, variations, annual reports, renewals, and related submissions.
• Perform regulatory assessments for change controls and deviations for assigned products by applying risk-based principles to categorize and prioritize post-approval changes.
• Collaborate with cross-functional stakeholders and peers within PDM, RA, Quality, Commercial, and other functions including local in-country colleagues, to define and execute endorsed global regulatory strategies and accomplish high-quality, and timely post-approval submissions.
• Monitor emerging regulatory guidance related to lifecycle management and apply it strategically to current and future submissions; identify opportunities to simplify lifecycle processes or accelerate submissions.
• Support development programs when required to accomplish CMC-RA deliverables and submissions.
• Provide guidance and mentorship to junior CMC-RA colleagues 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 supporting post-approval lifecycle management of small molecule products, particularly solid oral dosage forms.
• Strong knowledge of US and international regulations, current industry practices, with a demonstrated ability to interpret and apply requirements for commercial products.
• 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.
• Experience with other modalities regulated by CDER, e.g., antibody therapeutics, ADCs, etc.

#LI-CT1 #LI-Remote

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 can