Director, CDx Regulatory Consultant

Position Summary:

The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. This role will translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.

Essential functions of the job include but are not limited to:

Consulting Services

• Serve as the CDx regulatory subject matter expert for strategic positioning of client programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, an... Click Apply to read the full job description.