Director, Regulatory Affairs, Labeling

Revolution Medicines•Redwood City, CA

16h•Hybrid

About The Position

Revolution Medicines is seeking a Director of Regulatory Affairs Labeling, who will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late stage, and marketed products. This individual will manage regulatory labeling through all phases of development and post-approval, ensuring that the latest requirements and standards are met. This is an opportunity to join a growing regulatory organization and provide a direct impact on new label development and process initiatives at Revolution Medicines. 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.

Requirements

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.

Nice To Haves

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.

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.