Job title: Global Regulatory Affairs Associate Director - Diagnostics, IVDR
This role reports to the Head of Diagnostics Regulatory, Global Regulatory Affairs. The purpose of the Associate Director of Diagnostics Regulatory role is to provide international strategic, tactical, and operational strategies for Diagnostics to enable early-stage, late-stage and marketed compounds by supporting international clinical trials, market registration submissions, and post-approval submissions.
- Serves as the primary international regulatory subject matter expert in IVD development
- Develops and executes the international diagnostics regulatory strategy, including global diagnostic and molecule strategies.
- Provides high quality, timely and decisive regulatory advice to allow diagnostic development and therapeutic teams to make well-informed decisions on diagnostics development or product life cycle planning.
- Determines and communicates international submission and approval requirements and regulator expectations for the use of IVDs in clinical trials or registration of IVDs, including companion diagnostics.
- Act as a subject matter expert on IVDR (In Vitro Diagnostic Regulation) within the team and the broader business.
- At least a BSc in a related life/health science subject. Advanced degrees (MS, JD, PharmD, PhD) in health/life science would be preferred.
- At least five (5) years' experience in international diagnostics regulatory affairs (authority or industry) including extensive experience in a research-based diagnostics
- Knowledge of ICH and local regulatory authority regulations regarding therapeutic trials
- Demonstrate a deep understanding and knowledge of European Diagnostics regulations and procedures additional understanding of Japanese and/or Chinese diagnostic/companion devices regulations.
- Possess solid industry-related experience in the co-development of Diagnostics with therapeutic products.
- Extensive experience in a research-based diagnostics development role with strong regulatory affairs exposure.
Salary and benefits:
A highly competitive salary, annual bonus, car allowance and private medical insurance is on offer
To apply for this position or hear further details then please contact Matt Thomas via email@example.com