Overview
In this role you will lead CDx regulatory strategy for pharmaceutical, biotech, and diagnostic programs. You will partner with cross-functional teams to align diagnostic development, biomarker strategy, and clinical trial plans with regulatory expectations and commercialization goals. You will translate FDA, EU IVDR, and global requirements into actionable roadmaps, enabling trials and submissions for companion diagnostics and clinical trial assays. This position offers the opportunity to influence global regulatory pathways and drive lifecycle management for precision medicine programs. You will work with clients to shape regulatory strategies and engage with authorities to advance patient-
Verantwortungsbereiche
- Serve as the CDx regulatory subject matter expert for strategic client programs and global submission pathways
- Lead consulting engagements to develop global regulatory strategies, integrated development roadmaps, and milestone-based timelines
- Coordinate with cross-functional teams to ensure CDx activities align with program timelines and regulatory expectations
- Develop integrated Rx Dx regulatory strategies linking diagnostic development, biomarker strategy, and commercialization objectives
- Advise on regulatory requirements for assay use in clinical trials and related determinations and IRB considerations
- Direct preparation of global regulatory submissions and supporting documentation (FDA, EU IVDR, other country submissions)
- Lead interactions with regulatory authorities and notified bodies, including preparation for meetings and follow-up communications
- Review and direct development of validation plans, clinical protocols, statistical synopses, labeling, and submission-ready documents
- Apply IVD quality system and regulatory expertise to support CDx readiness through lifecycle
- Stay current on CDx regulatory developments and global trends
Zentrale Anforderungen
- Bachelor’s degree in life sciences or related field; equivalent experience considered
- Minimum 5 years of consulting experience focused on IVD, companion diagnostic, or precision medicine regulatory affairs
- Minimum 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment
- Direct experience with diagnostic manufacturers/labs and sponsors designing global regulatory and commercialization strategies for CDx and clinical trial assays
- Strong written and verbal communication translating complex CDx requirements into practical recommendations
- Strong scientific and analytical skills for interpreting biomarker, validation, and clinical trial data in CDx regulatory context
- Ability to solve complex CDx regulatory and submission challenges with risk-based solutions
- Leadership, cross-functional collaboration, and interpersonal skills across diagnostic development, clinical, quality, and commercial teams
- clear communication
- leadership
- cross-functional collaboration
- IVD
- companion diagnostic
- regulatory affairs
Director, CDx Regulatory Consultant in Heidelberg Arbeitgeber: Precision for Medicine
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und unterstützenden Umfeld zu arbeiten, das auf Qualität und kontinuierliche Verbesserung ausgerichtet ist. Unsere Unternehmenskultur fördert die persönliche und berufliche Entwicklung, während wir Ihnen flexible Arbeitsbedingungen und die Chance bieten, an bedeutenden Projekten in der klinischen Forschung teilzunehmen. Mit einem starken Fokus auf Teamarbeit und Innovation sind wir bestrebt, unseren Mitarbeitern ein erfüllendes und lohnendes Arbeitsumfeld zu bieten.
