OverviewScorra la pagina per visualizzare tutti i requisiti del lavoro e le responsabilità che i candidati selezionati dovranno assumersi.In this role you will support IDMP data integration and governance to strengthen regulatory processes.
You will work with the Regulatory Affairs team to ensure data quality and align with EMA SPOR services, contributing to compliant, structured submissions.
You will help improve processes and tools that enable efficient regulatory data management.
This is an opportunity to grow in a collaborative, growth-oriented environment focused on digitalizing regulatory workflows in the Life Sciences sector.Retribuzione / BenefitsPermanent employment contractHybrid working modelStructured training and professional development pathOpportunity to participate in innovative digital transformation projectsResponsabilitàSupport IDMP data mapping and gap analysis in line with EMA SPOR and regulatory requirementsAssist collection, structuring, validation, and maintenance of medicinal product data from internal regulatory systemsContribute to preparation of high-quality, structured regulatory submissionsSupport regulatory data governance to ensure data quality, consistency,

and integrityCollaborate with Regulatory Affairs to maintain regulatory compliance and data accuracyParticipate in development and continuous improvement of processes, templates, and tools for structured data submissionsPrepare documentation, guidance, and training materials related to IDMP, SPOR, and regulatory complianceContribute to cross-functional projects enhancing regulatory digitalization and data management practicesRequisiti fondamentaliDegree in Pharmacy, Pharmaceutical Chemistry and Technology (CTF), Biology, Biotechnology, Life Sciences, or related scientific disciplineMaster's degree in Regulatory Affairs is an xysqume advantageStrong interest in Regulatory Affairs and pharmaceutical complianceBasic understanding of the medicinal product lifecycle and regulatory submission processesInterest in regulatory data management, data governance, and digitalization of regulatory processesStrong analytical skills and attention to detailExcellent organizational and prioritization skillsProficiency in Microsoft Excelstrong analytical skillsattention to detailorganizational skillsMicrosoft ExcelIDMP data conceptsSPOR understanding

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