Senior Manager, Regulatory Affairs Process Excellence
Core
Manage Regulatory Affairs issue and CAPA systems, triage compliance issues, and drive process improvements to ensure inspection-ready operations.
Role type
Senior Manager, Regulatory Affairs Process Excellence
Builds
Compliant and efficient Regulatory Affairs operations
Domain
Life Sciences / Pharmaceutical Regulatory Affairs
Deliverable
dashboards & analysis
Required skills
Issue/CAPA system management, Exception reporting, Root cause analysis, Project management, Audit/inspection coordination, Change management, Stakeholder collaboration
Preferred skills
Advanced degree in science or business, Experience in Quality or Business Process Management, Experience with legacy company integrations
Technologies
RAIM, OneTrack
Responsibilities
Manage the Regulatory Affairs Issue and CAPA Management system (RAIM), Triage issue records to determine severity and next steps, Escalate issues to Exception Reports based on risk, Project manage Exception Reports to drive corrective actions, Collaborate with cross-functional stakeholders on audit readiness, Manage legacy company integrations via change plans
Seniority
Senior Manager, hands-on leadership
