Director, Regulatory Operations, Systems
Listed on 2026-09-13
-
IT/Tech
Change Management
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 OpportunityThe Director Regulatory Operations will partner closely with the Senior Director and Head of Regulatory Operations and Planning to build, lead, and scale Revolution Medicines’ regulatory information management capabilities. This role will set the strategy, oversee implementation, and manage optimization of the company’s global regulatory systems and processes, with a primary focus on the Veeva Vault RIM platform and associated technologies.
This is a build-and-scale role. The Director will provide hands-on leadership in establishing processes, optimizing systems, and ensuring operational excellence, while also shaping the long-term vision and future capabilities of the RIM function.
The role includes preparing the organization for future structured data submission requirements - such as Veeva Registrations, IDMP readiness, and eCTD 4.0 - and collaborating across Regulatory Affairs, Clinical Development, Quality, Information Sciences (IS), IT, and other functions to establish integrated global processes. The Director will also identify opportunities to introduce innovative solutions - such as automation or AI - where appropriate to improve efficiency and data quality.
Responsibilities- Partner with the Head of Regulatory Operations to establish and lead the Regulatory Information Management function, including governance, process ownership, and roadmap development.
- Define and execute the long-term RIM strategy to align regulatory systems and processes with business objectives and global compliance standards.
- Build the foundation for the RIM function by balancing strategic planning with hands-on leadership to establish processes, optimize systems, and drive operational excellence.
- Partner with stakeholders to prioritize initiatives, drive digital transformation, and ensure readiness for future regulatory data submission requirements.
- Position the RIM function as a strategic contributor by improving visibility, streamlining processes, and delivering business value through accurate, compliant regulatory data.
- Represent Regulatory Operations in planning discussions and enterprise initiatives, collaborating closely with cross-functional teams to deliver integrated solutions.
- Serve as the business owner for the Veeva Vault RIM platform, overseeing administration, configuration, data integrity, and ongoing enhancements.
- Manage system implementation, upgrades, validation, and change management activities.
- Collaborate with IT, Veeva, and vendors to integrate RIM with other enterprise systems (e.g., eTMF, CTMS, QMS) and ensure seamless workflows.
- Lead RIM release management, communicate system updates, and develop training plans to ensure optimal adoption.
- Oversee RIM data quality, including monitoring, governance, master data management, and compliance remediation.
- Establish metadata standards and implement processes to ensure consistent data stewardship across all…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).