Associate Director Inspection Management (GCP)

The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, build strategic partnerships working and liaising with Clinical Study teams, relevant functions and other GDQ functions to support teams with inspection preparation activities on all Regeneron-sponsored clinical trials.

Responsibilities

• Ensuring and managing the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
• Ensuring the preparation, management and integration of inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
• Providing effective guidance, consultancy, and support to the Clinical Study Teams (and any other key stakehol...