Location: IND36-01-Bengaluru-Kalyani Platina, Magnolia
Job Description Summary
The Head of Regulatory Information Management is accountable for the strategy, governance, operating model and performance of the company's RIM capability, including Regulatory Data Governance. The role sets direction for RIM systems, regulatory data standards, stewardship, quality metrics and continuous improvement across Regulatory Affairs, ensuring trusted regulatory data and effective tools support compliant, scalable business processes. Operational execution, hands-on data maintenance, system administration, document processing, routine system updates and training delivery are performed by designated process owners, business administrators and data stewards under their leadership.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Responsibilities
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.
Job description provided by GE HealthCare.
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