Director, CDx Regulatory Consultant

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, CDx Regulatory Consultant based in United States.

This role provides senior regulatory leadership across companion diagnostics (CDx), in vitro diagnostics (IVDs), and precision medicine programs.
You will advise pharmaceutical, biotechnology, diagnostic, and laboratory organizations on global regulatory strategy and commercialization pathways.
The position spans early development, clinical trial enablement, regulatory submissions, approval, launch, and lifecycle management.
You will translate complex FDA, EU IVDR, and international requirements into practical strategies that support coordinated Rx-Dx development.
The role combines scientific expertise, client consulting, regulatory leadership, business development, and team mentorship.
You will collaborate with multidisciplinary stakeholders to navigate complex diagnostic development and regulatory challenges.
This is an opportunity to shape sophisticated CDx programs while contributing to the growth of a specialized regulatory consulting practice.