Director, CDx Regulatory Consultant

The Director, CDx Regulatory Consultant role is being listed on behalf of a partner company managing all applications and next steps. The role requires strategic regulatory leadership for companion diagnostics (CDx), in vitro diagnostics (IVD), and precision medicine programs across global markets. Key responsibilities include guiding clients through complex regulatory pathways, translating scientific and clinical complexities into actionable plans, and shaping regulatory strategies.

Requirements

• Extensive experience in companion diagnostics, regulatory affairs, and consulting environments.
• Minimum 7+ years of experience, with 5+ years in direct consulting focused on CDx, clinical trial assays, precision medicine, or related regulatory programs.
• Proven experience developing global regulatory strategies for companion diagnostics and diagnostic products.
• Strong understanding of FDA, EU IVDR, and international regulatory requirements for IVD development and commercialization.
• Experience collaborating with pharmaceutical sponsors, diagnostic manufacturers, laboratories, and multidisciplinary development teams.
• Ability to interpret complex biomarker, assay validation, clinical performance, and diagnostic trial data to support regulatory decisions.
• Strong written and verbal communication skills with the ability to translate technical requirements into practical business recommendations.
• Demonstrated leadership, mentoring, and team-building capabilities across scientific, regulatory, quality, and commercial functions.
• Strong analytical thinking, problem-solving skills, and ability to provide risk-based solutions in complex regulatory situations.
• Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; Master’s degree or higher preferred.
• Regulatory Affairs Certification (RAC) is a plus.

Benefits

• Competitive compensation package based on experience, qualifications, and location.
• Opportunity to work remotely within the United States.
• Leadership role within a growing precision medicine and regulatory consulting environment.
• Opportunity to influence innovative diagnostic and therapeutic development programs.
• Exposure to global pharmaceutical, biotechnology, and diagnostic projects.
• Collaborative culture focused on scientific excellence, innovation, and professional growth.
• Opportunities to mentor teams and expand regulatory consulting capabilities.