Senior Specialist Regulatory Operations and System Support
Core
Coordinate and manage regulatory documentation and XEVMPD/IDMP submissions to health authorities, ensuring data quality and compliance with submission timelines.
Role type
Senior Specialist Regulatory Operations and System Support
Builds
Regulatory data submissions (xEVMPD/IDMP/SPOR PMS) and system process improvements for global healthcare products
Domain
Healthcare / Regulatory Affairs / Pharmacovigilance
Deliverable
client delivery
Required skills
EU regulations knowledge (Article 57, SPOR, IDMP), xEVMPD data submission expertise, Regulatory Information Management Systems (RIMS) experience, Document Management Systems (DMS) proficiency, numerical analysis (percentages, ratios, rates), stakeholder engagement, system administration
Preferred skills
Project management support, cross-functional collaboration, adaptability to new technologies
Technologies
XEVMPD software, RIMS, DMS, Adobe Acrobat, Microsoft Office Suite
Responsibilities
Maintain xEVMPD data ensuring quality and compliance; Respond to EMA and Health Authority queries; Provide registration tracking input; Coordinate communication with MA Coordinators and third parties; Support XEVMPD system administration; Reconcile xEVMPD/IDMP data with affiliates; Monitor regulatory updates and implement changes; Manage SPOR PMS data submissions
Seniority
Mid-Senior, hands-on IC