Associate Director, Operational and Digital Enablement, Regulatory Affairs CMC
Core
Lead business process design, optimization, and digital enablement initiatives to improve operational effectiveness and scalability within CMC Regulatory Affairs.
Role type
Associate Director, Operational and Digital Enablement
Builds
Sustainable process and digital solutions for CMC Regulatory Affairs
Domain
Pharmaceutical regulatory operations and digital transformation
Required skills
Business process design, process mapping, operational optimization, digital enablement, change management, cross-functional leadership, data-driven problem solving, regulatory lifecycle knowledge, stakeholder alignment, project management
Preferred skills
CMC Regulatory Affairs experience, pharmaceutical development background, experience with enterprise platforms (Veeva, Planisware, Signavio, Power BI), AI and automation implementation
Technologies
Veeva Vault, Planisware, Signavio, Visio, Power BI
Responsibilities
Lead business process mapping, analysis, design, and optimization; Identify operational pain points and inefficiencies; Facilitate cross-functional workshops to define current and future-state processes; Partner with IT and stakeholders to translate needs into digital solutions; Develop and monitor operational measures and KPIs; Drive organizational change initiatives for new processes and tools; Establish project objectives and implementation plans for complex cross-functional initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities