Director, CDx Regulatory Consultant
$162,000–$243,000 year
Remote
Job Summary
Lead consulting engagements to develop global companion diagnostic regulatory strategies, integrated development roadmaps, and submission pathways for pharmaceutical and biotechnology clients. Proactively identify client needs by understanding therapeutic programs, biomarker strategies, and commercial objectives to translate complex FDA, EU IVDR, and global regulatory requirements into actionable plans. Direct preparation of regulatory submissions including FDA Q-Submissions, IDEs, PMAs, and EU IVDR Annex XIV applications, while leading interactions with regulatory authorities and notified bodies. Manage and mentor regulatory consulting staff to support a scalable practice, ensuring quality and accuracy of all strategy documents and client deliverables. Generate new consulting opportunities through established relationships and lead client workshops focused on Rx Dx co-development and global IVD regulatory requirements.
Required Qualifications
- Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline
- Minimum 5 years of applicable consulting experience with a primary focus in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs
- Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment
- Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays
- Strong written and verbal communication skills
- Strong scientific and analytical skills
- Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions
- Strong leadership, team building, and interpersonal skills
Desired Qualifications
- Master's degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline
- RAC certification
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