Head of Regulatory Information Management

GE HealthCare; Bengaluru; Vor Ort; INR 4.000.000 - 7.000.000; Vollzeit

Zusammenfassung

GE HealthCare is seeking a Head of Regulatory Information Management to lead strategy, governance, and the operating model for the RIM capability. You will oversee data stewardship, quality metrics, and continuous improvement across Regulatory Affairs, ensuring trusted regulatory data and scalable business processes.

The role requires senior leadership, global program management and expertise in RIM systems such as Veeva Vault/RIM, with the ability to align cross-functional teams and drive

Qualifikationen

• 8+ years in regulatory affairs or regulatory operations with leadership experience.
• Experience leading global RIM or regulatory data capabilities.
• Strong governance, data quality, KPIs and lifecycle controls for regulatory master data.
• Strategic operating model development, budgeting and resource planning.
• Ability to influence senior stakeholders and align cross-functional teams.

Aufgaben

• Own the RIM strategy, roadmap and target operating model aligned to Regulatory Affairs and Quality.
• Lead and develop the RIM team, including recruitment, onboarding and performance management.
• Establish RIM governance forums to align priorities and decisions.
• Own the Regulatory Data Governance framework including data ownership, standards and KPIs.
• Set governance for RIM ecosystem (Veeva RIM, Lorenz docuBridge, AMS, IDMP/xEVMPD).
• Define resources and operating model for sustainable delivery and resilience.
• Monitor data quality and process metrics to drive improvements and CAPA effectiveness.
• Lead continuous improvement and transformation initiatives for global data sharing and automation.
• Ensure RIM systems meet QMS, GDP, data integrity and regulatory expectations.

Kenntnisse

RIM leadership

Regulatory data governance

Data quality KPIs

Strategic operating model

Change management

Stakeholder influence

Budget planning

GxP compliance

Tools

Veeva Vault/RIM

Jobbeschreibung

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.

Job Description

Roles and 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 worksharing, 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.

Required Qualifications

• 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.

Desired Characteristics

• 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.

Other Requirements

• Proficiency in spoken and written English
• Willing to attend local GE HealthCare office on an as-needed basis
• Willing to travel when required, but not more than 5-10%

Additional Information

Relocation Assistance Provided: No