Director, CDx Regulatory Consultant
Ladders · United States · 1 mo ago
RemoteRemoteLegal$162k–$243k/yrFull-time
Responsibilities
- Serve as the regulatory subject matter expert on companion diagnostics and global submission pathways
- Identify client needs based on comprehensive understanding of therapeutic programs and biomarker strategies
- Lead consulting engagements to develop global CDx regulatory strategies and integration roadmaps
- Collaborate with cross-functional teams to align CDx activities with regulatory expectations
- Advise on regulatory requirements for clinical trial assay use including risk determinations
- Direct preparation of global submissions and documentation for companion diagnostics
- Lead interactions with regulatory bodies, preparing for meetings and interpreting feedback
Qualifications
- Bachelor's degree in life sciences, molecular biology, genetics, pathology, regulatory affairs, or related discipline; equivalent experience considered
- 5+ years of consulting experience in IVD, companion diagnostics, clinical trial assays, or the company regulatory affairs
- 7+ years in an IVD, companion diagnostic, pharmaceutical or regulatory consulting environment
- Direct experience in designing global regulatory and commercialization strategies for diagnostics
- Strong communication skills to convey complex regulatory requirements into practical recommendations
- Leadership skills to guide multidisciplinary teams across various functions
Benefits
- Health insurance and retirement savings benefits
- Life insurance and disability benefits
- Parental leave and paid time off for sick leave and vacation
- Opportunities for professional development and mentoring
- Discretionary annual bonus eligibility