Director, Regulatory Affairs Companion Diagnostics (CDx)

Revolution Medicines•Redwood City, CA

5d•Hybrid

About The Position

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: 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. The Director will provide strategic regulatory leadership across all phases of companion diagnostic development, ensuring alignment between drug and diagnostic regulatory strategies, timelines, and submissions. This individual must possess a strong understanding of global in vitro diagnostic (IVD) regulations, companion diagnostic development, oncology drug development, and evolving global regulatory expectations. The successful candidate will be a collaborative leader with demonstrated experience managing complex cross-functional programs and interactions with health authorities and diagnostic partners.

Requirements

Advanced degree or bachelor’s degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics.
Demonstrated experience developing and executing global regulatory strategies for companion diagnostics supporting oncology or precision medicine programs.
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.
Excellent communication, leadership, negotiation, planning, and organizational skills with the ability to manage multiple complex programs simultaneously.
Experience representing Regulatory Affairs to senior leadership and executive governance committees.

Nice To Haves

Advanced degree (PhD, PharmD, MD, MS, or equivalent) is preferred.
Experience supporting global oncology registration programs involving companion diagnostics.
Working knowledge of EU IVDR implementation and international companion diagnostic regulations.
Experience supporting next-generation sequencing (NGS), PCR-based, or multiplex molecular diagnostics.

Responsibilities

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.
Provide strategic regulatory guidance for companion diagnostic development plans, analytical and clinical validation, bridging strategies, labeling, and lifecycle management.
Participate in regulatory interactions with FDA (CDRH and CDER), EMA, PMDA, and other global health authorities regarding companion diagnostic development and registration.
Partner closely with external diagnostic manufacturers to support successful co-development, regulatory submissions, inspections, and post-approval activities.
Ensure regulatory alignment between therapeutic and diagnostic submission timelines.
Provide regulatory leadership for biomarker and precision medicine strategies supporting patient selection and clinical trial enrollment.
Interpret evolving global regulations, guidance documents, and industry trends related to companion diagnostics and precision medicine, incorporating them into development strategies.
Represent Companion Diagnostics Regulatory Affairs on cross-functional development teams and to senior leadership.
Drive regulatory risk assessment and mitigation strategies to support development milestones and product approvals.
Develop and maintain strong collaborative relationships across Regulatory Science, Clinical Development, Translational Medicine, Commercial, and external partners.
Support development of regulatory policies, procedures, and best practices for companion diagnostics across the organization.