Director, CDx Regulatory Consultant

Consulting Services:

• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs, including FDA precedents, EU IVDR considerations, and global submission expectations.
• Develop integrated Rx Dx regulatory strategies that align diagnostic development, biomarker strategy, and clinical trial enrollment with therapeutic milestones.
• Direct the preparation of global regulatory submissions and supporting documentation, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, and EU IVDR performance study applications.

Business Development:

• Generate new CDx regulatory consulting opportunities through established relationships with pharmaceutical, biotechnology, and diagnostic stakeholders.
• Support bid defense meetings by communicating CDx regulatory pathways, submission risks, and agency interaction strategies to prospective clients.

Qualifications:

• Bachelor’s degree in life sciences, molecular biology, or related discipline with a minimum of 7 years of experience in IVD, companion diagnostic, or pharmaceutical regulatory consulting.
• Direct experience designing global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.
• Strong written and verbal communication skills with ability to translate complex regulatory requirements into practical client recommendations.