Regulatory Intelligence and Operational Excellence Lead
Core
Lead regulatory intelligence and operational excellence for Global Drug Regulatory Affairs, synthesizing global health authority guidance into actionable insights and harmonizing SOPs.
Role type
Senior regulatory intelligence and operational excellence lead
Builds
Regulatory intelligence frameworks, knowledge bases, SOP harmonization processes, and operational dashboards
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Regulatory intelligence, SOP governance, cross-functional stakeholder management, process improvement, data governance, strategic planning, project coordination
Preferred skills
GBS/shared services experience, NDA/MAA submission exposure, CMC/labeling/nonclinical background
Technologies
SharePoint, Microsoft Teams, RIMS, Citeline, RAPS
Responsibilities
Monitor health authority guidance and inspection trends; prepare intelligence briefs; maintain regulatory knowledge bases; coordinate SOP harmonization and lifecycle; map and improve cross-functional workflows; design onboarding programs; administer POA review cycles; maintain operational dashboards; partner with RA Operations on platform integration
Seniority
Senior, hands-on IC with strategic scope