Revolution Medicines · 2 days ago
Senior Manager, Regulatory Operations (Records & Information Management)
San Francisco Bay Area
Full-time
Hybrid
Senior Level
$164K/yr - $205K/yr
7+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. The Sr. Manager, Regulatory Operations is responsible for the compliant management, classification, and retrieval of regulatory submissions and health authority correspondence across the product lifecycle.
Health CareLife ScienceMedical
Responsibilities
Serve as the subject matter expert for regulatory submissions and health authority correspondence, including interpretation and classification of correspondence types (e.g., Information Requests, Study May Proceed letters, amendments, safety communications)
Execute and oversee the archiving of regulatory submissions and correspondence, ensuring accuracy, completeness, and retrievability throughout the record lifecycle
Define, maintain, and enforce archival and metadata standards, including controlled vocabularies and classification conventions, within Veeva Vault RIM
Monitor regulatory metadata quality and consistency across the system; identify, investigate, and drive remediation of data quality issues
Enable and train Regulatory Affairs staff and partners on proper document classification, metadata entry, and archival best practices
Support inspection readiness activities by ensuring regulatory correspondence and submissions are complete, traceable, and readily retrievable
Respond to regulatory documents and correspondence requests in support of business development due diligence, licensing, and partnership activities
Support Veeva Vault RIM business owners as needed
Partner cross-functionally with Regulatory Affairs, Quality, IT, and other stakeholders to continuously improve regulatory archiving and information management processes
Contribute to the development and maintenance of SOPs, work instructions, and best practices related to regulatory archiving and records management
Qualification
Required
Bachelor's degree required; advanced degree preferred
Minimum of 7–10 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Information Management, or related functions within the pharmaceutical or biotechnology industry
Demonstrated hands-on experience with Veeva Vault RIM, including regulatory document management, metadata usage, and records lifecycle management
Strong working knowledge of global regulatory submissions and health authority correspondence processes
Proven ability to apply archival standards and metadata practices in a regulated environment
Experience supporting inspection readiness and responding to regulatory or business-critical document requests
Strong attention to detail, organizational skills, and ability to manage work independently in a fast-paced environment
Excellent written and verbal communication skills, including the ability to train and guide cross-functional stakeholders
Preferred
Prior experience with regulatory submission publishing processes; hands-on publishing experience a plus
Experience supporting regulatory due diligence activities for business development, licensing, or mergers and acquisitions
Familiarity with records retention policies and regulatory archival requirements
Experience working in emerging or mid-size biotechnology organizations
Experience contributing to process improvement initiatives related to regulatory systems or information management
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Genetic Engineering News
2026-02-02
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase