Director, Regulatory Affairs Companion Diagnostics (CDx)
$211,000–$264,000 year
HybridRedwood City, California, United States
Job Summary
Develop and execute global regulatory strategies for companion diagnostics supporting oncology drug development 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 development plans, analytical and clinical validation, bridging strategies, labeling, and lifecycle management. Participate in regulatory interactions with FDA, 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. Drive regulatory risk assessment and mitigation strategies to support development milestones and product approvals. Represent Companion Diagnostics Regulatory Affairs on cross-functional development teams and to senior leadership.
Required Qualifications
- 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
- 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
Desired Qualifications
- Advanced degree (PhD, PharmD, MD, MS, or equivalent)
- 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
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