[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 tot his job Apply To this Job