Director, Regulatory Operations, Submissions

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 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 rigorall in service of patients.

The Opportunity:

• Lead and be accountable for global regulatory submission execution across all application types supporting increasing submission volume portfolio expansion and organizational growth.

• Provide strategic and operational leadership within Regulatory Operations contributing to functional direction capability planning and continuous improvement while maintaining strong executional accountability.

• Translate regulatory strategies into executable submission plans timelines resource requirements and operational approaches.

• Provide oversight for the planning preparation publishing submission and archiving of high-quality compliant global regulatory dossiers.

• Lead mentor and develop a submissions-focused team fostering accountability collaboration operational excellence and continuous improvement.

• Oversee external publishing vendors to ensure timely compliant high-quality execution and effective use of external resources.

• Define own and maintain submission-related standard operating procedures (SOPs) work instructions job aids standards policies and best practices to drive consistent execution across programs and regions.

• Drive continuous improvement of submission processes to reduce cycle times increase predictability improve quality and support organizational scale.

• Ensure submission processes and practices align with Quality systems regulatory requirements and inspection-readiness expectations.

• Partner closely with Regulatory Affairs Medical Writing Quality Clinical Operations and other cross-functional stakeholders to establish clear roles effective handoffs and coordinated execution across the submission lifecycle.

• Provide operational guidance and training to cross-functional contributors involved in regulatory submissions.

• Communicate complex submission issues and risks clearly and proactively developing practical solutions that balance compliance business needs and the demands of a growing portfolio.

• Advance cross-functional initiatives that improve Regulatory effectiveness and support broader departmental objectives.

• Partner with the Regulatory Systems lead to define business requirements provide operational input and ensure regulatory systems and processes effectively support submission execution.

Required Skills Experience and Education:

• Bachelors degree in a life science or related field with 12 years of experience in the biotechnology pharmaceutical or medical device industry.

• Seasoned people manager with demonstrated experience leading and developing high-performing teams.

• Proven leadership in developing and executing Regulatory Operations strategies within global biotechnology or biopharmaceutical organizations.

• Deep expertise in global submission planning and execution electronic Common Technical Document (eCTD) standards regulatory frameworks and Health Authority requirements.

• Demonstrated ability to contribute to operational strategy while maintaining strong accountability for submission execution quality and process excellence.

• Strong understanding of regulatory systems from a submissions operations business-process and end-user perspective.

• Experience leading process improvement initiatives within a regulated compliance-focused environment.

• Strong project and operational management skills with the ability to manage multiple priorities and deliver results in a dynamic environment.

• Clear and persuasive communicator with the ability to translate complex operational issues for technical cross-functional and senior stakeholders.

• Effective collaborator with demonstrated ability to influence and align cross-functional teams.

• Strategic thinker with a practical problem-solving mindset and ability to balance immediate execution needs with longer-term organizational scalability.

• Proficiency with DocuBridge and Veeva Regulatory Information Management (RIM).

Preferred Skills:

• Hands-on regulatory publishing experience with the technical capability to provide publishing support when needed.

• Experience using Smartsheet for submission planning project tracking and collaboration.

• Eperience supporting or managing a global regulatory portfolio.

#LI-JC1 #LI-Hybrid

We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms email phone or text message.

Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address.

If you believe youve been contacted by someone impersonating a Revolution Medicines recruiter please report it to so we can share these impersonations with our IT team for tracking and awareness.