Director, Regulatory Operations

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Director of Regulatory Information Management (RIM) 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:

Strategic Leadership & Function Building

• 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.

Veeva RIM Ownership & System Management

• 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 regulatory systems.

Global Submissions & Regulatory Process Optimization

• Drive continuous improvement of regulatory submission processes and tools to support global Health Authority interactions and international filing requirements.

• Provide strategic input into submission planning, timelines, and resource allocation.

• Partner with the Global Regulatory Affairs department to streamline workflows, reduce manual effort, and improve submission quality.

• Develop and maintain SOPs, work instructions, and job aids related to regulatory systems and submissions.

• Ensure processes and systems are designed to meet structured data submission requirements (e.g., Veeva Registrations, IDMP, eCTD 4.0).

Cross-Functional Collaboration & Stakeholder Engagement

• Partner with stakeholders across Regulatory, Clinical, Quality, IS, IT, and external vendors to align processes, resolve issues, and implement best practices.