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Director, CDx Regulatory Consultant at Precision Medicine Group - ApplyBlast

Director, CDx Regulatory Consultant

Precision Medicine Group

3 months ago

2.9 on Glassdoor

Remote

Full Time

Director

0 applicants

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About this role

The Director, CDx Regulatory Consultant will advise pharmaceutical, biotechnology, and diagnostic clients on companion diagnostic development, regulatory strategy, and lifecycle management across global markets. The role involves translating complex FDA, EU IVDR, and other regulatory requirements into actionable plans for clinical trial use, submissions, and commercialization.

Responsibilities

Develop global CDx regulatory strategies and submission roadmaps
Lead interactions with regulatory authorities and prepare submission documents
Generate new consulting opportunities and manage client engagements

Skills

Qualifications

Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or related fieldMaster's degree in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or related fieldRAC certification

About Precision Medicine Group

precisionmedicinegrp.com

Headquarters

Bethesda, Maryland, United States

Company Size

1001-5000 employees

Founded

2012

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Precision Medicine Group (PMG) is a consulting and solutions firm that helps pharmaceutical and life‑science companies accelerate drug development and improve patient outcomes by applying the discipline of precision medicine. PMG brings together specialized expertise in data and evidence generation, manufacturing, market access, and stakeholder engagement to unlock insights and speed commercialization. Focused on delivering measurable value, the company partners with innovators to advance development, strengthen access, and "move science closer to health."