Senior Manager, Global Regulatory Process and Compliance

Role: Senior Manager, Global Regulatory Compliance & Inspection Readiness, leading regulatory risk assessment, compliance programs, and inspection preparedness within a biopharma context. Responsibilities: conduct compliance risk assessments, oversee audit and inspection readiness, monitor regulatory processes and data quality (Veeva RIM), develop KPIs and dashboards, and implement continuous improvement initiatives. Serve as key liaison during audits/inspections, ensuring regulatory information integrity and inspection readiness. Requirements: Bachelor's in Life Sciences, Regulatory Affairs, or related field; 7+ years in Regulatory Affairs, Compliance, or GxP functions within pharma/biotech; strong knowledge of FDA, EMA, GxP, and data integrity principles; experience with regulatory info systems (preferably Veeva Vault RIM), audits, risk assessments, and trend analysis. Preferred: advanced degree, RAC or Six Sigma/Lean certification, and experience supporting health authority inspections. HighValue: global regulatory compliance, inspection readiness, GxP, regulatory info management, risk mitigation, cross-functional collaboration, and experience with regulatory audits. WorkSetup: hybrid, <15% travel.