Associate Director, Regulatory Systems

Revolution Medicines•Redwood City, CA

21d•Hybrid

About The Position

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Dir, RIM & DocuBridge Systems will serve as the system owner for Veeva RIM and DocuBridge platforms, supporting global regulatory operations. This role will be responsible for driving system strategy, ensuring compliance, and optimizing processes to enable efficient and scalable regulatory submissions and document management.

Requirements

Bachelor’s degree in Life Sciences, Information Systems, or related field.
8+ years of experience in Regulatory Systems or related domains.
Hands-on experience with RIM platforms (e.g., Veeva RIM) and document management systems such as DocuBridge.
Strong understanding of regulatory submission processes and document management workflows.
Experience with GxP validation and compliance frameworks (GAMP5, 21 CFR Part 11, Annex 11).
Demonstrated ability to manage cross-functional stakeholders and system implementations.
Strong analytical, problem-solving, and communication skills.

Nice To Haves

Experience with global regulatory submissions (eCTD) and health authority requirements.
Familiarity with integrations across RIM, eTMF, and other clinical/regulatory systems.
Experience with vendor management and managed services models.
Experience supporting system strategy and roadmap planning.

Responsibilities

Serve as system owner for Veeva RIM and DocuBridge platforms, ensuring alignment with Regulatory Affairs processes.
Lead system implementations, enhancements, and ongoing optimization efforts.
Partner with Regulatory Affairs and cross-functional stakeholders to gather and translate business requirements into system solutions.
Ensure systems are validated and maintained in compliance with GxP requirements (e.g., 21 CFR Part 11, Annex 11, GAMP5).
Establish and maintain system governance, including change control, release management, and documentation.
Support integration with related systems (e.g., eTMF, Quality, Safety, Clinical systems).
Collaborate with vendors to support system performance and issue resolution.
Develop training materials and support end-user adoption and best practices.
Support audits and inspections related to RIM and document management systems.