Associate Director, Regulatory Information Management & Innovation
Core
Design future releases and integrations for Regulatory Information Management (RIM) systems, driving AI-enabled capabilities and process innovations to meet Health Authority and business needs.
Role type
Senior IC regulatory information management lead (RIM) with AI/automation focus
Builds
RIM and submission platforms (e.g., Veeva RIM), AI-assisted solutions, automated workflows
Domain
Life sciences / Pharma / Regulatory Affairs / AI & Automation
Deliverable
production ML models | product features
Required skills
Global regulatory practices and submission guidelines, RIM system architecture, AI/automation strategy, cross-functional program management, risk mitigation, change management, validation rules, data quality optimization
Preferred skills
Expert knowledge of Global GxP requirements, strategic business planning, mentorship of SMEs, advanced analytics
Technologies
Veeva RIM, AI platforms, automation tools, analytics frameworks
Responsibilities
Lead evaluation, design, and adoption of AI-enabled capabilities across RIM platforms; Partner with business, IT, and vendors to define AI use cases and oversee pilot-to-production deployment; Maintain global expert knowledge of regulatory capabilities and processes; Lead system and process implementations according to validation rules; Broker delivery of critical programs ensuring organizational alignment on scope, schedule, and quality; Develop business plans to optimize regulatory capabilities
Seniority
Senior, hands-on IC with strategic oversight