Description

You will drive cross-functional development and execution of global regulatory labeling strategy for pipeline, late-stage, and marketed products at Revolution Medicines, a clinical oncology company. Manage labeling through all phases of development and post-approval, ensuring compliance with regulatory requirements and contributing to new label development and process initiatives.

Requirements

• Bachelor's degree in science or related discipline with 15+ years experience
• 8+ years in biotech/pharma leading product labeling across 2+ major geographic areas
• Ability to review labeling documents for accuracy and regulatory compliance
• Experience leading cross-functional meetings and negotiating labeling issues
• Detail-oriented with ability to deliver against tight timelines

Responsibilities

• Develop labeling strategy including Target Labeling, CCDS, USPI, EU SmPC
• Lead cross-functional Labeling Working Group and Senior Labeling Committee meetings
• Research competitor labeling and develop negotiation strategies with regulatory authorities
• Ensure quality and consistency of labeling deliverables through proofreading and QC
• Liaise with global regulatory authorities on labeling issues and changes