Head of Regulatory Information Management
Core
Lead the strategy, governance, and operating model for Regulatory Information Management (RIM) and regulatory data governance to ensure compliant, scalable business processes in life sciences.
Role type
Senior leadership, strategy & governance
Builds
RIM systems, regulatory data standards, and governance frameworks
Domain
Life Sciences / Regulatory Affairs / Data Governance
Deliverable
dashboards & analysis
Required skills
Strategic roadmap planning, team leadership, regulatory data governance, QMS/GxP/GDP compliance, change management, stakeholder alignment, data quality metrics, vendor governance
Preferred skills
Digital transformation, IT-enabled transformation, global registration lifecycle expertise, cross-functional decision making
Technologies
Veeva RIM, Lorenz docuBridge, AMS, xEVMPD, IDMP
Responsibilities
Own RIM strategy and target operating model; Lead RIM team development and performance management; Chair RIM and Regulatory Data Governance forums; Define regulatory data governance framework and lifecycle controls; Set strategic business ownership for RIM ecosystem; Monitor RIM performance metrics and drive risk-based improvements; Sponsor continuous improvement and transformation initiatives; Ensure RIM practices meet regulatory expectations.
Seniority
Senior, hands-on leader with strategic oversight