New · posted Oct 13
Revolution Medicines · Biotechnology
Senior Director, Regulatory Operations, Systems
- Redwood City, CA
- Hybrid
- Full-time
- Director
Closes Nov 12, 2026 · 30 days left
The role
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.
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.
What you need
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 Skillsnice to have
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.
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.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$244,000—$305,000 USD
What you'll do
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 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.
Pay and benefits
$244,000 – $305,000 a year
Employer providedCompetitive cash compensation
Equity awards
Strong benefits
Learning and development opportunities
Where you'll work
Redwood City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Redwood City, CAEqual opportunity, accessibility and legal noticesRevolution Medicines's statements, word for word
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact [email protected].
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.
If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to [email protected] so we can share these impersonations with our IT team for tracking and awareness.
Job intelligence
The context around this role
Live data · October 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 37% above the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $244,000 | — | $305,000 |
| All US (middle half) | $198,500 | $200,500 | $211,000 |
This role: Revolution Medicines's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 44 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Revolution Medicines's own promotion track.
Career resources on Regulatory Operations
Skills DNA
What this role leans on
How many of the posting's 50 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions14
- Data and digital systems12
- GMP and compliance7
- Quality systems and risk3
- Documentation and SOPs2
- Validation and qualification2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Revolution Medicines on Regulatory Jobs
- 17
- Open roles
- 17
- Distinct roles
- 2
- Locations
By discipline
- Regulatory8 47%
- Quality8 47%
- Compliance & Safety1 6%
By level
- Director14 82%
- Manager2 12%
- Senior & Principal1 6%
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Senior Director, Regulatory Operations, Systems at Revolution Medicines
Applications close November 12. $244K–$305K a year, employer provided.