[Remote] Regulatory Operations Specialist – XEVMPD
Note: The job is a remote job and is open to candidates in USA. Sagax 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.
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)
Skills
• 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
• Experience with eCTD compilation and publishing is a plus
Company Overview
• Sagax Team partners with Life Sciences companies, offering solutions in quality, compliance, and Lab Informatics. It was founded in 2018, and is headquartered in Schwenksville, Pennsylvania, USA, with a workforce of 11-50 employees. Its website is https://www.sagaxteam.com.
Apply Now
Apply Now
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)
Skills
• 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
• Experience with eCTD compilation and publishing is a plus
Company Overview
• Sagax Team partners with Life Sciences companies, offering solutions in quality, compliance, and Lab Informatics. It was founded in 2018, and is headquartered in Schwenksville, Pennsylvania, USA, with a workforce of 11-50 employees. Its website is https://www.sagaxteam.com.
Apply Now
Apply Now