Overview
Director, CDx Regulatory Consultant advising pharmaceutical, biotechnology, and diagnostic clients on companion diagnostic development, clinical trial use, approval, and lifecycle management.
What you'll do
- Serve as CDx regulatory subject matter expert for strategy, FDA precedents, EU IVDR considerations, and submission expectations.
- Lead consulting engagements to develop global CDx regulatory strategies and integrated development roadmaps.
- Partner cross-functionally to coordinate CDx development with therapeutic program timelines and regulatory expectations.
- Advise on regulatory requirements for assay use in clinical trials, including patient selection and risk determinations.
- Direct preparation of global regulatory submissions and supporting documentation (e.g., FDA Q-Submissions, IDEs, PMAs, EU IVDR Annex XIV applications).
- Lead interactions with regulatory authorities and notified bodies, including meeting preparation and response strategies.
What you'll need
- Minimum 5 years of applicable consulting experience focused on IVD, companion diagnostics, clinical trial assays, or precision medicine regulatory affairs.
- Minimum 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment.
- Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies.
- Strong written and verbal communication skills to translate complex CDx regulatory requirements into practical recommendations.
- Strong scientific and analytical skills to interpret biomarker, assay validation, clinical performance, and clinical trial information.
- Leadership and team-building skills to guide multidisciplinary teams across diagnostic, therapeutic, regulatory, quality, clinical, laboratory, and commercial functions.
- Bachelor’s degree in a relevant life science/regulatory discipline (or equivalent relevant experience).
Details
- Work mode: Remote.
- Location: Germany.
Read the full description and apply on the company’s own careers page.
