Director, Regulatory Affairs, Labeling at Revolution Medicines

You're a seasoned regulatory affairs professional with at least 15 years of experience, including 8 years in biotech or pharma focused on product labeling devel

Work type: hybrid

Location: Redwood City, California, United States

Salary: $211,000 – $264,000/yr

Type: Full-time

Summary

You're a seasoned regulatory affairs professional with at least 15 years of experience, including 8 years in biotech or pharma focused on product labeling development across multiple regions, holding a Bachelor's degree in science or a related field. **What makes it worth a look...** Revolution Medicines, a late-stage clinical oncology company, is offering a full-time Director, Regulatory Affairs, Labeling position with a base salary range of USD 211,000 - 264,000 per year. This role can be hybrid in Redwood City, CA, or remote with travel. **You might be a good fit if you...** * Have led the development and maintenance of product labeling across two or more major geographic areas. * Can review regulatory labeling documents for accuracy and adherence to requirements. * Have experience negotiating complex labeling issues with regulatory authorities. * Possess excellent verbal and written communication skills.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in 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.

• 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.

• 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

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.

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