The Senior Manager also serves as a key GRA partner for audits and inspections where Regulatory Affairs is host or in scope, leading readiness assessments, SME preparation, audit/inspection support, post-audit assessments, trend analysis, remediation oversight, and integration of lessons learned into the GRA compliance program. The Senior Manager partners across Global Regulatory Affairs and with Quality, Safety/Pharmacovigilance, Clinical, CMC, Regulatory Operations, and Regulatory Technology to ensure regulatory processes, information, and supporting systems remain compliant, inspection-ready, and aligned with global health authority expectations.