Director, Global Regulatory Labeling (Hybrid/Remote)

Revolution Medicines, Inc.; United States; Hybrid; USD 201,000 - 251,000; Full time

Job summary

Revolution Medicines is seeking a Director, Regulatory Affairs Labeling to drive global regulatory labeling strategy for pipeline, late-stage and marketed products. This role manages labeling development across all phases and ensures compliance with current requirements.

Based at our Redwood City, CA site in a hybrid schedule (remote option with travel) and with cross-functional collaboration across regions.

Qualifications

• Bachelor’s degree in science or related discipline.
• 12+ years in biotech/pharma leading labeling across two or more major geographic areas.
• Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements.
• 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.

Responsibilities

• Collaborate cross-functionally to develop labeling strategy.
• Manage development, review, and approval of labeling per regulatory requirements.
• Lead cross-functional Labeling Working Group and Senior Labeling Committee meetings.
• Maintain expertise on labeling requirements and stay current with guidelines/regulations.
• Research content of other labels to guide labeling text and strategy.
• Proofread and QC labeling deliverables; ensure alignment with data and regulatory requirements.
• Liaise and negotiate with global regulatory authorities as needed.
• Ensure dissemination of approved labeling documents and supporting documentation.
• Maintain controlled records for all labeling changes and communicate updates to stakeholders.
• Build partnerships with stakeholders from other functions to meet business goals.
• Participate in continuous improvement of the labeling process.
• Monitor global regulatory environment and assess impact on labeling activities.
• Facilitate policy development and updates with internal stakeholders.

Skills

Cross-functional leadership

Regulatory negotiation

Communication skills

Attention to detail

Team collaboration

Self-motivation

Labeling document review

Regulatory strategy

Global regulatory liaison

Education

Bachelor’s degree in science

Advanced degree in science

Job description

Revolution Medicines is seeking a Director, Regulatory Affairs Labeling to drive global regulatory labeling strategy for pipeline, late-stage and marketed products. This role manages labeling development across all phases and ensures compliance with current requirements.

Based at our Redwood City, CA site in a hybrid schedule (remote option with travel) and with cross-functional collaboration across regions.