Associate Director, Regulatory AI Capability Lead

Overview

In this role you will drive regulatory operations improvements and digital enablement for CMC regulatory affairs. You will map and optimize processes, collaborate with cross-functional teams, and implement data-driven solutions to boost efficiency and compliance. You’ll lead and support digital initiatives, measurement of impact, and change management to enable faster, higher-quality regulatory delivery. This is a hands-on, impact-focused opportunity to shape regulatory workflows in a global setting.

Responsibilities

• Lead business process mapping, analysis, design, and optimization across CMC Regulatory Affairs (development, registration, post-approval, lifecycle management)
• Identify operational pain points and opportunities for simplification or digital enablement with process owners and SMEs
• Apply structured problem-solving and data-driven approaches to diagnose root causes and design practical solutions
• Facilitate cross-functional workshops to define current and future-state processes and implementation plans
• Develop and maintain process standards, governance, and controls for consistent execution
• Develop and monitor KPIs to assess process performance and adoption
• Support portfolio, resource, and operational planning; use enterprise planning tools
• Partner with digital enablement peers to translate needs into digital solutions and use cases
• Lead or support implementation of digital solutions from requirements through testing, deployment, and adoption
• Establish success metrics for AI-enabled capabilities and analyze business value
• Evaluate automation, analytics, AI opportunities to improve regulatory processes and decision-making
• Support data quality improvements and integration of processes, data, content, and systems
• Develop dashboards and operational insights to drive data-driven decisions
• Support user acceptance testing, change management, and adoption of new capabilities
• Promote scalable process management and digital best practices across the function

Key requirements

• Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or related regulated environment
• Experience leading business process design, mapping, optimization, or operational improvement initiatives
• Experience translating business needs into technical requirements and partnering with IT to implement solutions
• Experience leading complex, cross-functional initiatives in global, matrixed organizations
• Strong understanding of pharmaceutical regulatory processes; CMC regulatory processes preferred
• Familiarity with regulatory information management, workflow, data, analytics, automation, or AI-enabled solutions
• Experience with platforms such as Veeva Vault, Planisware, Signavio, Visio, Power BI or similar
• Ability to analyze complex problems, structure ambiguity, and drive implementation
• Strong facilitation and stakeholder engagement skills across functions
• Lean, Lean Six Sigma or process improvement training/certification desirable

• Strong communication and influencing skills
• Cross-functional collaboration
• Stakeholder management
• Regulatory information management
• Workflow design and automation
• Data analytics and visualization

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