Senior Manager, Regulatory Affairs Labeling

Revolution Medicines; United States; Hybrid; USD 150,000 - 189,000; Full time

Job summary

Revolution Medicines is seeking a Senior Manager of Labeling to develop and maintain regional labeling aligned with global CCDS strategy. The role oversees cross-functional reviews, coordinates with external vendors, and ensures timely delivery of labeling documents for regulatory submissions.

The position can be based in Redwood City, CA in a hybrid setup or remote with travel; strong collaboration with Global Labeling is required and experience across multiple regions is essential.

Qualifications

• Bachelor's degree in scientific, pharmacy, life sciences, or related discipline.
• 7+ years in pharma/biotech regulatory labeling across multiple geographies.
• Ability to review regulatory labeling documents for accuracy and regulatory compliance.
• Experience drafting regional labeling from CCDS or reference label.
• Experience overseeing external labeling vendors and submissions across regions.
• Experience with electronic document management and version control.

Responsibilities

• Partner with the Global Labeling Lead to translate strategy into regional labeling plans and timelines.
• Author and maintain regional prescribing information using CCDS or reference labels.
• Assess impact of CCDS changes and coordinate updates with regional Regulatory Affairs.
• Identify differences between local labeling and CCDS; escalate deviations.
• Oversee vendor performance and ensure quality, timelines, and approvals.

Skills

Regulatory labeling experience

Project management

Cross-functional communication

Attention to detail

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Regulatory information management systems

Document management 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 Manager of Labeling serves as a labeling support strategist, partnering with the Global Labeling Lead to execute global labeling deliverables for assigned products. The role develops and maintains regional labeling using the Company Core Data Sheet (CCDS) or an approved reference regional label, adapting content to applicable local requirements while preserving alignment with global labeling strategy. The Senior Manager prepares labeling documents directly or oversees their preparation by external vendors. In both cases, the individual is accountable for document quality, timely delivery, and management of all required cross-functional review and approval activities through completion, in accordance with company procedures and designated approval authorities.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

Labeling Development and Strategic Support

• Partner with the Global Labeling Lead to translate global labeling strategy into actionable regional and country labeling plans, including deliverables, dependencies, timelines, and review requirements.

• Author, revise, and maintain regional prescribing information and patient labeling, as applicable, using the CCDS or an approved reference regional label and relevant supporting documentation

• Assess the impact of CCDS changes, reference label updates, new clinical or safety information, and health authority feedback on assigned labeling; coordinate required updates with regional Regulatory Affairs.

• Identify and document differences between proposed local labeling and the CCDS or reference label. Develop recommendations and coordinate review, escalation, and approval of deviations through established governance processes.

• Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables.

Vendor Oversight

• Define the scope, source documents, content expectations, timelines, and quality standards for outsourced labeling activities; provide clear instructions and ongoing guidance.

• Review vendor-prepared documents for accuracy, completeness, consistency with source labeling, and alignment with applicable requirements. Ensure comments are resolved and deliverables are ready for internal review and approval.

• Monitor vendor performance and elevate quality, resource, or timeline concerns to relevant vendor management stakeholders.

Review and Approval Management

• Own coordination of required reviews and approvals for assigned labeling, regardless of whether documents are authored internally or by a vendor. Identify reviewers and approvers, establish schedules, and manage review and approval workflows through completion.

• Facilitate cross-functional review, consolidate feedback, resolve comments, and drive alignment on proposed content.

• Prepare review materials, document decisions and their rationale, and elevate unresolved content or strategic issues to the Global Labeling Lead.

• Ensure required approvals are obtained and recorded before documents are released for submission or implementation; maintain approved versions, annotations, supporting references, and an auditable decision history.

Delivery and Process Improvement

• Coordinate with regional and local Regulatory Affairs and Regulatory Operations to provide approved labeling for submission, support responses to labeling queries, and track implementation status.

• Maintain accurate project trackers and controlled document repositories; communicate progress, risks, and mitigation plans. Support inspection readiness and improvements to labeling procedures, templates, and vendor workflows.

Required Skills, Experience and Education:

• Bachelor's degree in scientific, pharmacy, life sciences, or related discipline.

• At least 7+ years of pharmaceutical or biotechnology industry experience supporting regulatory labeling in at least two or more major geographic areas.

• Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements.

• Demonstrated experience preparing regional labeling from a CCDS or reference label and managing cross-functional document review and approval.

• Experience overseeing external labeling vendors, managing labeling deviations, and supporting labeling submissions across multiple regions.

• Experience with electronic document management and regulatory information management systems, including controlled review workflows, version control, and approval records.

• Detail oriented and highly organized with the ability to deliver against tight timelines.

• Strong project management and communication; ability to manage competing priorities and resolve issues in a global matrix organization.

Preferred Skills:

• Advanced degree in science or other related discipline.

• 9+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.

#LI-JC1 #LI-Remote

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 NoticeandPrivacy Policy.For additional information, please [e-mail].

Base Pay Salary Range

$150,000-$189,000 USD

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