Director, Regulatory Affairs, Labeling

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 14 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:

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.

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.

Required Skills Experience and Education:

Bachelors 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 Skills:

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. #LI-Hybrid #LI-SH1

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

$204000$255000 USD

Required Experience:

Director