Director, Regulatory Affairs Companion Diagnostics

The Director, Regulatory Affairs Companion Diagnostics is accountable for developing and executing global regulatory strategies for companion diagnostics supporting Revolution Medicines' precision oncology portfolio. This individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics.

What You Will Do

Develop and execute global regulatory strategies for companion diagnostics supporting oncology drug development programs from early development through commercialization. Serve as the Regulatory Lead for companion diagnostic programs, ensuring coordinated regulatory strategies between therapeutic and diagnostic products.

Why It Might Be a Fit

The successful candidate will be a collaborative leader with demonstrated experience managing complex cross-functional programs and interactions with health authorities and diagnostic partners. They will possess a strong understanding of global in vitro diagnostic (IVD) regulations, companion diagnostic development, oncology drug development, and evolving global regulatory expectations.

Requirements

• Advanced degree or bachelor’s degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline
• Minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience
• At least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics
• Deep knowledge of FDA companion diagnostic guidance, PMA requirements, IDE regulations, IVDR, and global IVD regulatory frameworks
• Experience leading regulatory interactions with FDA CDRH and CDER, EMA, PMDA, and other international health authorities
• Demonstrated success managing regulatory aspects of drug-diagnostic co-development programs through product approval
• Experience working with external diagnostic partners
• Strong understanding of biomarker development, assay validation, analytical performance studies, clinical performance studies, and companion diagnostic lifecycle management
• Proven ability to influence cross-functional teams and integrate regulatory strategy across drug and diagnostic development organizations

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities