Head of Regulatory Information Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Take ownership and lead the RIM strategy, roadmap, and target operating model, ensuring alignment with Regulatory Affairs, Regulatory Operations, Quality, and enterprise data and digital priorities.

• Guide and develop the RIM team, encompassing recruitment, onboarding, capability enhancement, succession planning, and performance management, while promoting an inclusive and accountable team culture.

• Establish and preside over RIM and Regulatory Data Governance forums to align priorities, facilitate cross-functional decisions, address escalations, and uphold clear ownership of systems, processes, and data.

• Manage the Regulatory Data Governance framework, which includes data ownership and stewardship, data standards, quality thresholds, KPIs, issue escalation, and lifecycle controls for regulatory master data.

• Determine strategic business ownership and governance for the RIM ecosystem, ensuring that investment and release priorities align with business requirements.

• Define the necessary resources and operating model 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, utilizing insights to drive risk-based enhancements, CAPA effectiveness, leadership decisions, and prioritization.

• Champion continuous improvement and transformation initiatives that simplify processes, enhance data integrity, increase automation, and facilitate global worksharing.

⛳️ Requirements

• A minimum of 8 years of experience in Regulatory Affairs, Regulatory Operations, or Regulatory Information Management within a regulated life sciences setting.

• Proven leadership in people management and strategic operating models, including budget and resource planning, performance management, capability development, and change leadership in a matrixed environment.

• Comprehensive 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.

• Proficiency in both spoken and written English.

• Willingness to visit the local GE HealthCare office as needed.

• Readiness to travel as required, though not exceeding 5-10%.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid time off

• A 401(k) plan with opportunities for both employee and company contributions

• Life insurance

• Disability insurance

• Accident insurance

• Tuition reimbursement