Partner with leadership and cross-functional stakeholders to maintain a continuous state of inspection readiness, ensure effective execution of regulatory inspections and audits, foster high-quality regulatory interactions, and drive timely responses to inspection and audit observations, CAPAs, and continuous improvement initiatives. Provide strategic leadership across Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biometrics, Data Management, Quality, and external partners to promote sustainable compliance, operational excellence, and inspection success throughout the product development lifecycle.