Director, CDx Regulatory Consultant

Accountabilities: The Director, CDx Regulatory Consultant will lead strategic consulting engagements, providing expert guidance on companion diagnostic development, regulatory submissions, and commercialization strategies. The role requires strong collaboration with pharmaceutical sponsors, diagnostic partners, clinical teams, and internal stakeholders to deliver high-quality regulatory solutions.

Serve as a subject matter expert in companion diagnostics, IVD regulatory strategy, clinical trial assays, and global approval pathways.

Develop and execute integrated CDx regulatory strategies aligned with therapeutic development goals, biomarker programs, clinical timelines, and commercialization objectives.

Advise clients on FDA, EU IVDR, and global regulatory expectations, including submission pathways, performance studies, and diagnostic development requirements.

Lead preparation and review of regulatory documentation, including FDA Q-Submissions, Pre-IDE packages, IDEs, PMAs, PMA supplements, technical documentation, and international submissions.

Support regulatory authority and notified body interactions by preparing meeting materials, response strategies, and follow-up communications.

Guide analytical validation plans, clinical performance strategies, diagnostic protocols, statistical approaches, labeling, and technical documentation.

Partner with cross-functional teams including clinical operations, quality assurance, laboratories, biostatistics, commercial teams, and therapeutic development groups.

Apply IVD quality system knowledge, design controls, risk management principles, and lifecycle management strategies to support successful product development.

Identify and develop new consulting opportunities through client relationships, industry networks, and business development activities.

Support proposals, client presentations, workshops, and educational sessions focused on CDx strategy and precision medicine innovation.

Ensure accuracy, consistency, and regulatory quality across consulting deliverables, client documentation, and strategic recommendations.

Mentor and support consulting team members while contributing to a collaborative and growth-oriented regulatory practice.

Requirements:

The ideal candidate brings extensive experience in companion diagnostics, regulatory affairs, and consulting environments, with the ability to navigate complex scientific and commercial challenges while communicating effectively with diverse stakeholders.

Bachelor’s degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline; equivalent experience considered.

7+ years of experience within IVD, companion diagnostics, pharmaceutical, biotechnology, or regulatory consulting environments.

Minimum 5 years of direct consulting experience focused on CDx, clinical trial assays, precision medicine, or related regulatory programs.

Proven experience developing global regulatory strategies for companion diagnostics and diagnostic products.

Strong understanding of FDA, EU IVDR, and international regulatory requirements for IVD development and commercialization.

Experience collaborating with pharmaceutical sponsors, diagnostic manufacturers, laboratories, and multidisciplinary development teams.

Ability to interpret complex biomarker, assay validation, clinical performance, and diagnostic trial data to support regulatory decisions.

Strong written and verbal communication skills with the ability to translate technical requirements into practical business recommendations.

Demonstrated leadership, mentoring, and team-building capabilities across scientific, regulatory, quality, and commercial functions.

Strong analytical thinking, problem-solving skills, and ability to provide risk-based solutions in complex regulatory situations.

Master’s degree or higher in a relevant scientific discipline is preferred.

Regulatory Affairs Certification (RAC) is a plus.

Benefits:

Competitive compensation package based on experience, qualifications, and location.

Opportunity to work remotely within the United States.

Leadership role within a growing precision medicine and regulatory consulting environment.

Opportunity to influence innovative diagnostic and therapeutic development programs.

Exposure to global pharmaceutical, biotechnology, and diagnostic projects.

Collaborative culture focused on scientific excellence, innovation, and professional growth.

Opportunities to mentor teams and expand regulatory consulting capabilities.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether? 

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