Regulatory specilist
Pubblicato il 24-10-2026 - ARITHMOS in Monza
Milano or Verona, Italy We are experts in the Life Sciences industry & Technology. We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains. We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
Job Description
We are seeking a JuniorRegulatory Specialist to join our Regulatory Affairs team. The successful candidatewill support the integration of IDMP (Identification of Medicinal Products) standards into regulatory processes, contributing to regulatory data quality,governance, and lifecycle management in alignment with EMA SPOR servicesand international regulatory requirements. KeyResponsibilities
* Support IDMP datamapping and gap analysis activities in alignment with EMA SPOR servicesand regulatory requirements.
* Assist in thecollection, structuring, validation, and maintenance of medicinal productdata from internal regulatory systems (e.g., RIM platforms and databases).
* Contribute to thepreparation of high-quality, structured regulatory submissions.
* Support regulatorydata governance initiatives to ensure data quality, consistency, andintegrity.
* Collaborate with theRegulatory Affairs team to maintain regulatory compliance and dataaccuracy.
* Participate in thedevelopment and continuous improvement of processes, templates,
and toolssupporting structured data submissions.
* Assist in thepreparation of documentation, guidance documents, and training materialsrelated to IDMP, SPOR, and regulatory compliance.
* Contribute tocross-functional projects aimed at enhancing regulatory digitalization anddata management practices. Requirements
* Degree in Pharmacy, Pharmaceutical Chemistry and Technology(CTF), Biology, Biotechnology, Life Sciences, or a related scientificdiscipline.
* A Master's degree inRegulatory Affairs is considered an advantage.
* Strong interest inRegulatory Affairs and pharmaceutical compliance.
* Basic understandingof the medicinal product lifecycle and regulatory submission processes.
* Interest inregulatory data management, data governance, and the digitalization ofregulatory processes.
* Strong analyticalskills and attention to detail.
* Excellentorganizational and prioritization skills.
* Proficiency in Microsoft Excel.
* Classification underthe Italian National Collective Labour Agreement (CCNL Commercio)
* Annual gross salary(RAL) between €25,000 and € 30.000 based on experience andqualifications.
* Employee benefits
* Structured trainingand professional development path.
* Opportunity toparticipate in innovative digital transformation projects within the LifeSciences sector.
* A collaborative,dynamic, and growth-oriented working environment. #J-18808-Ljbffr