Sagax Team · 1 day ago
Regulatory Operations Specialist – XEVMPD
United States
Contract
Remote
Senior Level, Lead/Staff
8+ years expSagax Team is looking for a Regulatory Operations Specialist who can manage end-to-end XEVMPD submissions and ensure compliance with EMA requirements. The role involves maintaining product data accuracy and supporting regulatory operations tasks while collaborating with cross-functional teams.
BioinformaticsData IntegrationSoftware
Hiring Manager
Rohit Tyagi
Responsibilities
Own all XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) data entry, updates, and maintenance for authorized and investigational products
Prepare, validate, and submit XEVPRM files via the EVMPD gateway
Ensure compliance with EMA requirements, data standards, controlled vocabularies, and submission timelines
Coordinate with Regulatory Affairs for product changes (variations, renewals, line extensions) and update XEVMPD data accordingly
Review source documents (SmPC/PI, MAH data, manufacturing info) to confirm accuracy before submission
Maintain audit-ready documentation and support regulatory inspections
Support other regulatory operations tasks: eCTD submissions, RIM data updates, regulatory archiving, and document management
Partner with PV teams to ensure alignment between XEVMPD and safety-related data (EudraVigilance)
Qualification
Required
8-10 years in Regulatory Operations within pharma/biotech
Direct experience with XEVMPD data entry and XEVPRM submissions (must-have)
Strong understanding of EMA regulatory framework, EudraVigilance, and EU product lifecycle requirements
Experience working with RIM tools (e.g., Veeva RIM, Liquent, ArisGlobal, Lorenz)
Detail-driven, organized, and comfortable handling high-volume data work
Strong communication skills and ability to work with cross-functional teams
Preferred
Experience with eCTD compilation and publishing is a plus
Company
Sagax Team
Sagax Team partners with Life Sciences companies, offering solutions in quality, compliance, and Lab Informatics.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Rohit Tyagi
President
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