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
Builds
Actionable intelligence briefs, knowledge bases, and harmonized SOPs for Global Drug Regulatory Affairs
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Regulatory intelligence, global health authority guidance monitoring, SOP governance, knowledge management, cross-functional collaboration, strategic thinking, data visualization
Preferred skills
GBS/shared services experience, NDA/MAA submission exposure, CMC/labeling background, SharePoint/Teams/RIMS proficiency
Technologies
SharePoint, Teams, RIMS, Citeline, RAPS
Responsibilities
Monitor health authority guidance and inspection trends; prepare intelligence briefs and reports; capture internal learnings in a searchable knowledge base; coordinate SOP harmonization and lifecycle; map and improve cross-functional regulatory workflows; administer POA review cycles; maintain dashboards for SOPs and training; partner with RA Operations to integrate intelligence into platforms.
Seniority
Senior, hands-on IC with strategic ownership