Regulatory Specilist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ol9a0

Overview
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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 / Benefits
Permanent employment contract
Hybrid working model
Structured training and professional development path
Opportunity to participate in innovative digital transformation projects
Responsabilità
Support IDMP data mapping and gap analysis in line with EMA SPOR and regulatory requirements
Assist collection, structuring, validation, and maintenance of medicinal product data from internal regulatory systems
Contribute to preparation of high-quality, structured regulatory submissions
Support regulatory data governance to ensure data quality, consistency, and integrity




Collaborate with Regulatory Affairs to maintain regulatory compliance and data accuracy
Participate in development and continuous improvement of processes, templates, and tools for structured data submissions
Prepare documentation, guidance, and training materials related to IDMP, SPOR, and regulatory compliance
Contribute to cross-functional projects enhancing regulatory digitalization and data management practices
Requisiti fondamentali
Degree in Pharmacy, Pharmaceutical Chemistry and Technology (CTF), Biology, Biotechnology, Life Sciences, or related scientific discipline
Master's degree in Regulatory Affairs is an xysqume advantage
Strong interest in Regulatory Affairs and pharmaceutical compliance
Basic understanding of the medicinal product lifecycle and regulatory submission processes
Interest in regulatory data management, data governance, and digitalization of regulatory processes
Strong analytical skills and attention to detail
Excellent organizational and prioritization skills
Proficiency in Microsoft Excel
strong analytical skills
attention to detail
organizational skills
Microsoft Excel
IDMP data concepts
SPOR understanding

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ol9a0