Senior Manager, Regulatory Operations (Records & Information Management)

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Sr. Manager Regulatory Operations (Archiving & Information Management) is a senior individual contributor role responsible for the compliant management classification and retrieval of regulatory submissions and health authority correspondence across the product lifecycle. This role serves as the subject matter expert for regulatory correspondence archival standards and metadata governance within Veeva Vault Regulatory Information Management (RIM) with accountability for metadata consistency and inspection readiness. Core responsibilities include defining and enforcing archival and metadata standards overseeing regulatory archiving activities enabling and training Regulatory Affairs users to correctly classify records and supporting inspections and business development due diligence through accurate complete and readily retrievable regulatory records.

While this role is currently centered on hands-on regulatory archiving and correspondence management it is expected to evolve over time as automation and system maturity increase with greater emphasis on regulatory information management and metadata strategy within Veeva Vault RIM. Accountability for the integrity consistency and retrievability of regulatory records will remain constant throughout this evolution.

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.

Required Skills Experience and Education:

Bachelors degree required; advanced degree preferred.
Minimum of 710 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 Skills:

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.
#LI-Hybrid #LI-JC1

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.

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 ourCCPA additional information please contact .

Base Pay Salary Range

$164000$205000 USD

Required Experience:

Senior Manager