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
Builds
Optimized regulatory processes, digital/AI-enabled workflows, and data-driven operational insights for CMC Regulatory Affairs
Domain
Pharmaceutical industry, CMC Regulatory Affairs, Process Improvement
Required skills
Business process design and optimization, Cross-functional stakeholder leadership, Digital transformation and automation strategy, Regulatory lifecycle management, Data analytics and dashboarding, Change management
Preferred skills
Lean Six Sigma certification, Experience with Veeva Vault/Planisware/Signavio, AI-enabled solution implementation
Technologies
Veeva Vault, Planisware, Signavio, Visio, Power BI, AI tools
Responsibilities
Lead business process mapping and optimization for CMC Regulatory Affairs; Partner with IT and business owners to implement digital and AI-enabled solutions; Drive cross-functional initiatives to align processes with global regulatory requirements; Develop and monitor KPIs for operational performance and digital adoption.
Seniority
Senior, hands-on IC with strategic oversight