Director, CDx Regulatory Consultant

This remote Director, CDx Regulatory Consultant role focuses on advising pharmaceutical, biotech, and diagnostic clients on companion diagnostic strategy, development, clinical trial support, approval, and later-stage management. Day to day, the work includes shaping regulatory plans, mapping submission routes, supporting patient selection assays, planning analytical and clinical validation, preparing trial-enabling filings, and helping align diagnostic and therapeutic launches. It also involves leading consulting projects and working with therapeutic teams, diagnostic makers, laboratories, biostatistics, clinical operations, quality, and commercial colleagues. The advert names companion diagnostic regulation, IVD development, quality system expectations, FDA requirements, EU IVDR, global marketing authorization pathways, biomarker strategy, assay technology, and clinical trial design as key knowledge areas. It does not state any specific qualification, years of experience, or language requirement. The role is remote, with no office or shift pattern mentioned. It appears suited to someone with deep regulatory experience in CDx and IVD work who can turn complex requirements into practical development and commercialization plans.