Overview
In this role you will lead CDx regulatory strategy for pharmaceutical, biotechnology, and diagnostic clients, translating global requirements into practical plans. You will shape regulatory pathways for companion diagnostics and clinical trial assays, aligning biomarker strategies with development, approval, and commercialization. You’ll work with cross-functional teams to manage submissions, interactions with authorities, and lifecycle management, contributing to Precision for Medicine’s broader CDx capabilities.
Verantwortungsbereiche
- Serve as the CDx regulatory expert for strategic program positioning and global submission expectations
- Lead multi-disciplinary consulting engagements to develop integrated regulatory roadmaps and timelines
- Coordinate with therapeutic development, diagnostics, QA, statistics, and commercial teams to align CDx activities with program milestones
- Advise on regulatory requirements for assay use in clinical trials, including patient selection and trial-level regulatory considerations
- Prepare global regulatory submissions and supporting documents (FDA Q-Submissions, IDEs, EU IVDR Annex XIV, etc.)
- Engage with regulatory authorities and notified bodies, including meeting preparation, feedback interpretation, and response planning
- Oversee development of analytical validation plans, clinical performance studies, and labeling for CDx programs
- Apply IVD quality systems, risk management, and post-market regulatory expertise to support lifecycle management
- Stay current on CDx regulatory developments and market trends
Zentrale Anforderungen
- Bachelor's degree in life sciences or related field; equivalent experience considered
- Minimum 5 years of consulting experience focused on IVD/CDx/regulatory affairs
- Minimum 7 years in an in vitro diagnostic or regulatory consulting environment
- Experience working with diagnostic manufacturers and pharmaceutical sponsors on global CDx strategies
- Strong written and verbal communication translating complex CDx requirements into practical client guidance
- Strong analytical skills for interpreting biomarker, assay validation, and clinical performance data
- Proven ability to lead cross-functional teams and solve complex regulatory challenges
- Preference for Master’s or higher and RAC certification
- Strong communication skills
- Leadership and team-building
- Cross-functional collaboration
- CDx regulatory strategy
- FDA and EU IVDR submission knowledge (Q-Submissions, IDEs, PMAs, Annex XIV)
- IVD quality systems, design control, risk management
