SeniorManagerClinicalStudyInspectionReadiness

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 Claude — to accelerate deliverable production, strengthen documentation quality, and drive continuous improvement in inspection readiness operations, with all AI-assisted outputs subject to human review and full GCP compliance **A typical day in this role looks like:** **Serve as:** * CTM Inspection Readiness point of contact leading GCP inspection readiness programs across complex, multi-program clinical portfolios involving both internal teams including CRO partners, and Inspection Management. * Project manager during the inspection process (mock, dry run and/or actual) and assist, and/or lead (as needed) the CTM team with follow up requests from the inspector/inspection management team during mock and actual inspection(s). **Provide guidance and support to Clinical Trial Management as follows:** * Work with Clinical Study Team (CST) and functional areas to support CTM in providing responses to the Q&A sessions held by Inspection Management for Inspection Readiness, support action item