Director, CDx Regulatory Consultant

About the role

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.

Responsibilities

• Serve as a senior CDx regulatory subject matter expert, advising clients on regulatory positioning, FDA precedents, EU IVDR requirements, global submission expectations, and diagnostic commercialization pathways.
• Assess therapeutic programs, biomarker strategies, intended-use populations, assay technologies, clinical trial designs, and commercial objectives to identify regulatory needs and opportunities.
• Lead consulting engagements and develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-driven timelines.
• Develop integrated Rx-Dx strategies that align diagnostic development, biomarker planning, clinical trial enrollment, therapeutic milestones, and commercialization objectives.
• Advise on the regulatory use of assays in clinical trials, including patient selection, inclusion and exclusion testing, risk determinations, IRB considerations, investigational device requirements, and international performance study obligations.
• Direct preparation of regulatory submissions and supporting documentation, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, EU IVDR performance study applications, technical documentation, and country-specific submissions.
• Lead interactions with regulatory authorities and notified bodies, including meeting preparation, agency feedback interpretation, response strategies, meeting documentation, and follow-up communications.
• Review and direct analytical validation plans, clinical performance studies, diagnostic clinical protocols, statistical analysis plans, technical reports, intended-use statements, labeling, and other submission-ready materials.
• Apply expertise in IVD quality systems, design controls, risk management, and post-market regulatory requirements throughout the CDx development lifecycle.
• Monitor regulatory, scientific, and market developments, including FDA guidance, EU IVDR implementation, notified body expectations, global regulatory trends, diagnostic precedents, and evolving precision medicine requirements.
• Support business development by identifying consulting opportunities, evaluating proposals, assessing regulatory risks, and defining CDx submission strategies and timelines.
• Participate in bid defense meetings, client workshops, scientific conferences, and educational presentations focused on CDx development, Rx-Dx co-development, clinical trial assays, and global IVD regulation.
• Advise on statements of work, change orders, master service agreements, and related contractual documentation to ensure regulatory scope, deliverables, assumptions, and responsibilities are clearly defined.
• Ensure the quality, consistency, and regulatory accuracy of consulting deliverables, submissions, strategy documents, and client-facing materials.
• Mentor, manage, and develop regulatory consulting professionals while contributing to a collaborative and client-focused consulting environment.
• Maintain accurate time reporting and follow established standard operating procedures and quality practices.

Requirements

• Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent relevant experience may be considered.
• At least 5 years of consulting experience focused on IVD, companion diagnostics, clinical trial assays, precision medicine, or related regulatory affairs.
• At least 7 years of experience in an IVD, companion diagnostic, pharmaceutical, or regulatory consulting environment.
• Direct experience working with diagnostic manufacturers, laboratories, and pharmaceutical sponsors to develop global regulatory and commercialization strategies for CDx and clinical trial assays.