Assoc Director, Business Strategy and Operations
Core
Lead business process mapping, optimization, and digital enablement initiatives for CMC Regulatory Affairs to improve operational efficiency and compliance.
Role type
Senior Associate Director, Business Strategy and Operations (Regulatory)
Builds
Optimized regulatory processes, digital automation solutions, and data-driven operational dashboards for CMC Regulatory Affairs.
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Business process design and optimization, cross-functional stakeholder leadership, regulatory lifecycle management, digital solution implementation, data analytics, change management, strategic planning
Preferred skills
Lean Six Sigma, CMC regulatory expertise, enterprise platform proficiency (Veeva, Planisware, Signavio), AI/automation strategy
Technologies
Veeva Vault, Planisware, Signavio, Visio, Power BI, AI-enabled tools
Responsibilities
Lead business process mapping and optimization for CMC Regulatory Affairs; Partner with IT and business owners to define and implement digital solutions; Facilitate cross-functional workshops to establish process standards and governance; Develop and monitor KPIs for process performance and digital adoption; Drive organizational change initiatives for new processes and tools; Translate operational needs into business requirements for technology teams.
Seniority
Senior, hands-on IC with strategic oversight