Director, Regulatory AI Business Partner
Core
Senior business partner bridging AI for Clinical Development and Regulatory functions to prioritize AI use cases, ensure compliance, and deliver value in drug development.
Role type
Director, Regulatory AI Business Partner
Builds
Enterprise-level AI capabilities and compliant AI solutions for regulatory workflows
Domain
Biopharma / Life Sciences / Regulatory Affairs / AI in Clinical Development
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Stakeholder management, AI/ML strategy, regulatory compliance (GxP), data governance, buy-vs-build decision making, vendor evaluation, cross-functional collaboration, roadmap planning
Preferred skills
Regulatory Affairs experience, Health Authority (FDA/EMA) knowledge, clinical data management, drug development operations
Technologies
AI/ML frameworks, data pipelines, cloud infrastructure, regulatory submission tools
Responsibilities
Partner with AI and Regulatory teams to develop and prioritize AI solutions; Ensure AI solutions meet regulatory standards and compliance requirements; Translate business needs into AI opportunities and business cases; Coordinate with IT and data teams on infrastructure and data access; Advise on vendor selection and build-vs-buy decisions; Define success metrics and track AI adoption benefits
Seniority
Director, strategic leadership with hands-on business partnering