Head of Regulatory Information Management

Overview

Lead the strategy, governance, operating model and performance of GE HealthCare's Regulatory Information Management (RIM) capability, including Regulatory Data Governance.

What you'll do

• Own and lead the RIM strategy, roadmap and target operating model, aligned to Regulatory Affairs, Regulatory Operations, Quality and enterprise data and digital priorities.
• Lead and develop the RIM team, including recruitment, onboarding, capability building, succession planning and performance management, while fostering an inclusive and accountable team culture.
• Establish and chair RIM and Regulatory Data Governance forums to align priorities, make cross-functional decisions, resolve escalations and maintain clear ownership of systems, processes and data.
• Own the Regulatory Data Governance framework, including data ownership and stewardship, data standards, data quality thresholds, KPIs, issue escalation and lifecycle controls for regulatory master data.
• Set strategic business ownership and governance for the RIM ecosystem, including Veeva RIM, Lorenz docuBridge, AMS, xEVMPD/IDMP processes and related integrations, ensuring investment and release priorities support business needs.
• Define the resource and operating model needed for sustainable delivery and resilience, delegating operational execution to designated business administrators, process owners and data stewards.
• Monitor RIM, regulatory data quality and process performance metrics, using insights to drive risk-based improvements, CAPA effectiveness, leadership decisions and prioritisation.
• Sponsor continuous improvement and transformation initiatives that simplify processes, strengthen data integrity, improve automation and enable global work-sharing, acting as steering leader rather than day-to-day project manager.
• Ensure RIM systems, processes and data governance practices meet QMS, GDP, data integrity and regulatory expectations, and represent RIM/Data Governance in Regulatory Operations leadership, cross-functional governance and selected external/industry interactions.

What you'll need

• 8+ years of experience in Regulatory Affairs, Regulatory Operations or Regulatory Information Management in a regulated life sciences environment, including leadership of global RIM, regulatory systems or regulatory data capabilities.
• Demonstrated people leadership and strategic operating model experience, including budget and resource planning, performance management, capability development and change leadership in a matrix environment.
• Strong understanding of RIM business applications and regulatory data governance, QMS/GxP/GDP, change control, data integrity, regulatory compliance, IDMP/xEVMPD expectations and global registration/submission lifecycle processes.

Nice to have

• Ability to influence senior stakeholders and align cross-functional teams around shared standards, governance decisions and strategic priorities.
• Experience establishing regulatory data governance, stewardship models, data quality KPIs, issue management and lifecycle controls for regulatory master data.
• Experience shaping digital and data roadmaps, vendor governance and IT-enabled transformation across Veeva Vault/RIM and related regulatory systems.
• Strong analytical, communication and change management capability, with ability to convert metrics, risks and data quality signals into strategy and effective decisions.

Details

• Location: Bengaluru, Kalyani Platina, Magnolia (India).
• Relocation assistance: not provided.