Regulatory Intelligence and Operational Excellence Lead
Core
Own the regulatory intelligence and knowledge-sharing framework for Global Drug Regulatory Affairs, monitoring health authority guidance and synthesizing insights for leadership.
Role type
Senior regulatory intelligence lead (pharmaceuticals)
Builds
Actionable intelligence briefs, searchable knowledge bases, and harmonized SOPs for Global Drug Regulatory Affairs
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Global regulatory guidance monitoring, intelligence synthesis, SOP governance, knowledge management platform administration, cross-functional workflow mapping, onboarding program design, data dashboarding
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 and reports; maintain dashboards for SOPs and training; coordinate onboarding programs; harmonize SOPs with process owners; map and improve cross-functional workflows; administer POA review cycles
Seniority
Senior, hands-on IC