Associate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety )
Core
Provides compliance oversight across Global Patient Safety and Regulatory Affairs, monitoring indicators, inspection-readiness, and operational performance for clinical programs.
Role type
Senior IC Regulatory Affairs Director
Builds
Compliance frameworks, inspection readiness, and regulatory documentation for clinical programs
Domain
Pharmaceutical industry, Regulatory Affairs, Global Patient Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance monitoring, SOP management, risk analysis, quality event investigation, stakeholder collaboration, training matrix management, health authority submission support
Preferred skills
Audit and regulatory inspection support, strategic regulatory planning
Technologies
Trial Master File, regulatory information management systems
Responsibilities
Monitor regulatory compliance activities including SmPC updates and health authority submissions; Ensure Regulatory Affairs documentation accuracy within Trial Master File; Oversee timely updates to Regulatory Affairs SOPs and procedures; Monitor and analyze key compliance metrics and trends; Support quality event investigations including root cause analysis and CAPA; Partner with cross-functional teams to support health authority inspections; Provide quality-related training for Regulatory Affairs team members
Seniority
Senior, hands-on IC