Associate Director, Regulatory Information Management & Innovation
Core
Design future releases and integrations for Regulatory Information Management (RIM) systems, evolving functionality to meet Health Authority and business needs while leading AI-enabled capability adoption.
Role type
Associate Director, Regulatory Information Management & Innovation
Builds
RIM and submission platforms (e.g., Veeva RIM) with AI/automation features
Domain
Life Sciences / Regulatory Affairs / AI & Automation
Deliverable
production ML models | product features
Required skills
Global regulatory practices and submission guidelines, RIM or submissions experience, AI/automation/advanced analytics strategy, system validation, project management, cross-functional leadership, risk mitigation, change management
Preferred skills
Science or technology degree background, computer systems knowledge in R&D environments
Technologies
Veeva RIM, AI platforms, automation tools
Responsibilities
Maintain comprehensive knowledge of Regulatory Capabilities and Processes; Identify and track progress against key project milestones; Engage with leadership from business case development through program delivery; Support development of processes compliant with Global GxP requirements; Lead system and process implementations according to validation rules; Lead evaluation, design, and adoption of AI-enabled capabilities; Partner with business, IT, and vendors to define AI use cases and oversee pilot-to-production deployment; Support business case approval for improvement projects; Lead development of business plans to optimize regulatory capabilities
Seniority
Senior, hands-on IC with strategic oversight