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.