[Remote] Regulatory Operations Specialist – XEVMPD

Note: The job is a remote job and is reputed company 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 reputed company XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary) data entry, updates, and maintenance for authorized and investigational products • Prepare, validate, and submit XEVPRM files reputed company 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 reputed company documents (SmPC/PI, MAH data, manufacturing info) to confirm accuracy before submission • Maintain audit-reputed company 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-reputed company data (EudraVigilance) Skills • 8-10 years in Regulatory Operations reputed company reputed company/biotech • reputed company experience with XEVMPD data entry and XEVPRM submissions (must-have) • Strong understanding of EMA regulatory reputed company, EudraVigilance, and EU product lifecycle requirements • Experience working with RIM tools (e.g., reputed company RIM, Liquent, reputed company, 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 reputed company • Sagax reputed company with Life Sciences companies, offering solutions in reputed company, compliance, and Lab Informatics. It was founded in 2018, and is headquartered in Schwenksville, reputed company, USA, with a workforce of 11-50 employees. Its website is https://www.sagaxteam.com. Apply tot his job Apply To this Job