Regulatory specilist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8onz7b

h3Overview /h3 pIn 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. /p h3Retribuzione / Benefits /h3 ul liPermanent employment contract /li liHybrid working model /li liStructured training and professional development path /li liOpportunity to participate in innovative digital transformation projects /li /ul h3Responsabilità /h3 ul liSupport IDMP data mapping and gap analysis in line with EMA SPOR and regulatory requirements /li liAssist collection, structuring, validation, and maintenance of medicinal product data from internal regulatory systems /li liContribute to preparation of high-quality, structured regulatory submissions /li liSupport regulatory data governance to ensure data quality, consistency,



and integrity /li liCollaborate with Regulatory Affairs to maintain regulatory compliance and data accuracy /li liParticipate in development and continuous improvement of processes, templates, and tools for structured data submissions /li liPrepare documentation, guidance, and training materials related to IDMP, SPOR, and regulatory compliance /li liContribute to cross-functional projects enhancing regulatory digitalization and data management practices /li /ul h3Requisiti fondamentali /h3 ul liDegree in Pharmacy, Pharmaceutical Chemistry and Technology (CTF), Biology, Biotechnology, Life Sciences, or related scientific discipline /li liMaster's degree in Regulatory Affairs is an advantage /li liStrong interest in Regulatory Affairs and pharmaceutical compliance /li liBasic understanding of the medicinal product lifecycle and regulatory submission processes /li liInterest in regulatory data management, data governance, and digitalization of regulatory processes /li liStrong analytical skills and attention to detail /li liExcellent organizational and prioritization skills /li liProficiency in Microsoft Excel /li /ul ul listrong analytical skills /li liattention to detail /li liorganizational skills /li liMicrosoft Excel /li liIDMP data concepts /li liSPOR understanding /li /ul #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8onz7b