Director, CDx Regulatory Consultant
Core
Director-level regulatory consultant advising pharma/biotech clients on companion diagnostic (CDx) development, clinical trial assays, and global marketing authorization pathways.
Role type
Senior IC regulatory consultant (CDx/IVD)
Builds
Global regulatory strategies, submission packages (FDA Q-Subs, IDEs, PMAs, EU IVDR), and commercialization roadmaps for companion diagnostics.
Domain
Life Sciences / In Vitro Diagnostics (IVD) / Companion Diagnostics
Deliverable
client delivery
Required skills
CDx regulatory strategy, IVD development, global marketing authorization, FDA/EU IVDR compliance, clinical trial assay design, analytical validation planning, risk management, business development, team leadership
Preferred skills
Master's degree in life sciences/regulatory affairs, RAC certification
Technologies
None stated
Responsibilities
Lead consulting engagements to develop global CDx regulatory strategies and submission pathways; Direct preparation of regulatory submissions (FDA Q-Subs, Pre-IDE, PMAs, EU IVDR); Lead interactions with regulatory authorities and notified bodies; Manage and mentor regulatory consulting staff; Generate new CDx consulting opportunities and support bid defense.
Seniority
Director, hands-on IC with leadership
