Senior Specialist Regulatory Operations and System Support
Core
Coordinate regulatory documentation and XEVMPD/IDMP submissions to health authorities while supporting system administration and project management for regulatory efficiency.
Role type
Senior Specialist Regulatory Operations and System Support
Builds
Regulatory data submissions (xEVMPD/IDMP/SPOR) and system updates for health authorities
Domain
Healthcare / Regulatory Affairs
Required skills
EU regulations knowledge (Article 57, SPOR, IDMP), xEVMPD data submission expertise, Regulatory Information Management Systems (RIMS), Document Management Systems (DMS), Adobe Acrobat, Microsoft Office Suite, stakeholder engagement, time management, numerical analysis
Preferred skills
Experience with regulatory systems projects, ability to learn new technologies
Technologies
XEVMPD software, RIMS, DMS, Adobe Acrobat, Microsoft Office Suite
Responsibilities
Maintain xEVMPD data ensuring quality and compliance, respond to EMA/Health Authority queries, provide registration tracking input, coordinate with MA Coordinators/third parties, support XEVMPD system administration (user management, updates), reconcile data with affiliates, monitor regulatory updates, manage SPOR PMS data submissions
Seniority
Senior, hands-on IC