Senior Director, Regulatory Affairs Program Modernization
Core
Lead the strategic evolution and modernization of the Controlled Substances Monitoring Program (CSMP) through process transformation, AI-enabled capabilities, data governance, and automation.
Role type
Senior Director, Regulatory Affairs Program Modernization
Builds
Scalable, technology-enabled solutions for regulatory compliance, audit readiness, and operational excellence within the CSMP.
Domain
Healthcare regulatory affairs and digital transformation
Deliverable
production ML models
Required skills
Strategic roadmap development, cross-functional program leadership, regulatory compliance, AI and automation integration, data governance, change management, executive stakeholder influence
Preferred skills
Responsible AI principles, model governance, enterprise operating model design, vendor/partner management, organizational change adoption
Technologies
Artificial Intelligence, automation, data analytics, digital modernization tools
Responsibilities
Develop and execute the strategic roadmap for CSMP modernization; Partner with Regulatory Affairs, Legal, Compliance, and Technology to implement scalable solutions; Evaluate current-state processes to identify efficiency and compliance improvements; Lead the design of future-state operating models; Drive cross-functional programs and establish program governance; Ensure AI solutions align with privacy, auditability, and governance standards; Design change management strategies; Maintain regulatory compliance and audit readiness; Provide executive-level recommendations on modernization priorities.
Seniority
Senior Director, strategic leadership and cross-functional program ownership
