Senior Director, Regulatory Operations, Systems

Revolution Medicines, Inc.; San Francisco (CA); On-site; USD 244,000 - 305,000; Full time

Job summary

Revolution Medicines, Inc. is seeking a Senior Director of Regulatory Information Management (RIM) to build and scale global regulatory systems, led by Veeva Vault RIM. The role shapes strategy, governance, and data quality across Regulatory Affairs, Clinical Development, Quality and IS.

Based in Redwood City, CA, this onsite position emphasizes process optimization, regulatory submissions readiness (IDMP, eCTD 4.0) and opportunities for automation and AI to drive efficiency.

Qualifications

• 14+ years in biotech/pharma/medical device with 7+ years in Regulatory Affairs/Operations and Veeva RIM
• Experience with EU, Japan, and Canada submissions
• Proven leadership building functions and leading cross-functional initiatives
• Excellent communication, stakeholder engagement and change management skills
• Experience with IT system architecture, cloud solutions, and GxP compliance

Responsibilities

• Lead Regulatory Information Management function, governance and roadmap
• Define long-term RIM strategy aligned with global compliance
• Oversee data quality, master data management and metadata standards
• Collaborate with IT, Veeva, and vendors for system integrations
• Prepare for structured data submissions (Veeva Registrations, IDMP, eCTD 4.0)
• Partner with stakeholders to drive digital transformation and readiness

Skills

Veeva Vault RIM

Regulatory Affairs/Operations

Leadership

Stakeholder engagement

Change management

Communication

Education

Bachelor's degree in Life Sciences, Engineering, Information Systems, or related field

Advanced degree preferred

Tools

Veeva Vault RIM

eCTD 4.0

IDMP readiness

Regulatory submissions systems

Job description

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 Opportunity:

The Senior Director of Regulatory Information Management (RIM) will partner closely with the Executive Director and Head of Regulatory Operations 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 Seior 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.

Key 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 with strategic planning 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.
• Serve as the primary liaison between Regulatory Affairs and system vendors to ensure compliance and functionality meet evolving business needs.
• Engage proactively with business partners to demonstrate the value of regulatory data and systems, positioning the RIM function as a key enabler rather than a back-office resource.
• Provide expertise to support inspections, audits, and regulatory authority interactions related to RIM systems and data.

Leadership, Hiring & Team Development

• Build, mentor, and manage a high-performing team responsible for regulatory systems and data management.
• Currently manage four direct report, with potential to expand the team as the function evolves.
• Develop and deliver training programs to improve system utilization and regulatory compliance.
• Promote a culture of innovation, operational excellence, and continuous improvement within Regulatory Affairs.

Innovation & Emerging Technologies

• Evaluate and recommend innovative solutions — such as automation or AI — where appropriate to improve regulatory data management, submissions, and reporting.
• Stay current with evolving regulatory technology trends and propose enhancements that deliver measurable business value.

Required Skills, Experience and Education:

• Bachelor’s degree in a life science, technical, or related field with 14+ years of experience in the biotechnology, pharmaceutical, or medical device industry, with at least 7 years focused on Regulatory Affairs/Operations and Veeva RIM systems (administration, configuration, and optimization).
• Experience submission managmen in EU, Japan, and Canada.
• Proven leadership experience, including building functions, managing small teams, and leading cross-functional initiatives.
• Strong understanding of global regulatory submission requirements and evolving Health Authority standards.
• Expertise in eCTD specifications, electronic submissions, and regulatory publishing standards.
• Experience with system implementation, validation, and compliance under GxP regulations.
• Excellent communication, stakeholder engagement, and change management skills, with the ability to influence and drive adoption across diverse teams.
• Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field (advanced degree preferred).

Preferred Skills:

• Expert level knowledge of Veeva Vault RIM and related regulatory systems.
• Experience supporting oncology drug development and regulatory submissions across the full product lifecycle (IND through post-marketing).
• Experience with structured data submissions, including Veeva Registrations, IDMP readiness, and eCTD 4.0 standards.
• Prior experience in digital transformation initiatives, including system integrations and process automation.
• International experience with global submissions and regional regulatory requirements.
• Understanding of IT system architecture, cloud solutions, and integrations in a GxP-regulated environment.

Base Pay Salary Range

$244,000 - $305,000 USD

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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