Senior Manager Clinical Study Inspection Readiness

The **Senior Manager, Clinical Study Inspection Readiness** , leads all Good Clinical Practice (GCP) inspection readiness activities for one or more assigned clinical programs within Clinical Trial Management (CTM). Reporting to senior leadership and partnering closely with Program Operations Leaders (POLs) and Clinical Study Leads (CSLs), this role owns the preparation, organization, and execution of inspection readiness strategy in accordance with International Council for Harmonization (ICH)/GCP guidelines, Regeneron Standard Operating Procedures (SOPs), Work Instructions (WIs), and Business Practice Tools (BPTs). The role provides inspection readiness leadership across both internally sourced studies and those outsourced to Clinical Research Organizations (CROs), serving as the primary CTM point of contact for all inspection-related activities. This role is expected to leverage Artificial Intelligence (AI)-powered tools — including large language model (LLM) applications such as C...