Associate Specialist, Regulatory Affairs - Hybrid
Core
Support Global Regulatory Affairs operations for Health Registration Management (HRM) and Veeva Registrations, ensuring smooth system transitions, compliance reporting, and lifecycle management for marketed and clinical products.
Role type
Associate Specialist, Regulatory Affairs (Business Process Operations)
Builds
Global HRM and Veeva Registrations platform support, process documentation, training resources, and compliance submissions.
Domain
Life Sciences / Regulatory Affairs / Health Technology
Deliverable
product features
Required skills
Change Controls, Change Management, Documentation Preparation, Employee Training Programs, Meeting Facilitation, Process Implementations, Regulatory Communications, Regulatory Processes, Regulatory Reporting
Preferred skills
Business Systems, Regulatory Applications
Technologies
Veeva Vaults (Veeva Registrations), MS Office (Word, Excel, PowerPoint, Teams)
Responsibilities
Transition and maintain current process documentation and create new resources; Provide training and education support including content transition and user feedback implementation; Support Change Management by creating global communications and facilitating multi-modality delivery; Gather requirements with SMEs to ensure timely delivery; Support Change Control Board (CCB) meetings and track metrics; Update HRM website contents for real-time material delivery.
Seniority
Associate, hands-on IC