Key Responsibilities

• Lead and develop a high‑performing RIMs team to deliver seamless day‑to‑day regulatory operations.

• Oversee creation and maintenance of regulatory applications for NPIs, safety variations, and lifecycle activities.

• Provide subject‑matter expertise and operational support for regulatory activities managed within centralized RIMs systems.

• Manage workflows for timely delivery of critical regulatory reports (e.g., Status, Product Quality, WWMAS) supporting supply, manufacturing, PV inspections, and governance.

• Own XeVMPD submissions and ongoing maintenance of registered product data.

• Ensure accuracy, integrity, and completeness of registered product and master data across global markets (LATAM, METAP, APAC, EU, India, and others).

• Maintain and update SOPs and Work Instructions for assigned workstreams, ensuring continuous audit and inspection readiness.

• Support regulatory audits and health authority inspections through RIMs expertise, data extraction, and documentation.

• Lead User Acceptance Testing (UAT) and related testing for new features, system enhancements, or major RIMs implementations.

• Drive continuous improvement, data quality excellence, and compliance with global regulatory requirements.

• Manage team performance, capability building, and career development.

Required Expertise

• Strong knowledge of global regulatory regulations and guidelines.

• Hands‑on experience with industry‑standard RIMs tools and regulatory systems.

• Proven people leadership and stakeholder management capability.