Revolution Medicines · 1 week ago
Director, Regulatory Affairs, Labeling
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
$211K/yr - $264K/yr
15+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. They are seeking a Director of Regulatory Affairs Labeling, who will drive the development and execution of global regulatory labeling strategies for their products.
Health CareLife ScienceMedical
Responsibilities
Collaborate cross-functionally to develop labeling strategy
Manage development, review, and approval of high-quality labeling, including Target Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements
Lead cross-functional Labeling Working Group and Senior Labeling Committee meetings
Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles
Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities
Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents)
Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to labeling including resolution of key regulatory issues and labeling changes
Ensure the dissemination of approved labeling documents and supporting documentation
Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation
Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise
Participate in any relevant continuous improvement efforts for the end-to-end labeling process
Monitor global regulatory environment and assess impact of changes on business and product labeling activities
Facilitate policy development and updates with internal stakeholders
Qualification
Required
Bachelor's degree in science or other related discipline with 15+ years relevant experience
8+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas
Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies
Experience leading cross functional meetings and facilitating strategic discussions
Experience negotiating with internal stakeholders and regulatory authorities on complex labeling issues
Excellent verbal/written communication skills and strong judgment and decision making
Detail oriented and highly organized with the ability to deliver against tight timelines
Proven ability to achieve goals within a cross-functional team environment and as an individual contributor and interact effectively with all levels/roles with a high level of professionalism
The candidate should be a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment
Preferred
Advanced degree in science or other related discipline
10+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas
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
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase