Director, Regulatory Operations, Submissions

Revolution Medicines•Redwood City, CA

1d•$211,000 - $264,000•Hybrid

About The Position

Revolution Medicines is a global, commercial-stage 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: 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.

Requirements

Bachelor’s 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).

Nice To Haves

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.
Experience supporting or managing a global regulatory portfolio.

Responsibilities

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.