Regulatory specilist

ARITHMOS; Verona; Hybrid; EUR 32,000 - 52,000; Full time

Benefits offered by this job

Hybrid working model

Structured training and professional发展

Opportunities in digital regulatory202

Job summary

ARITHMOS cerca un profilo nel settore regolatorio per supportare l'integrazione dei dati IDMP e la governance dei dati regolatori, contribuendo a submission strutturate conformi alle norme EMA SPOR.

Si lavora in un contesto ibrido e orientato al digitale, sviluppando processi e strumenti per migliorare l'efficienza delle attività regolatorie. Laurea in campi scientifici e forte interesse per Regulatory Affairs richiesti.

Qualifications

• Laurea in Farmacia, Chimica Farmaceutica e Tecnologia o disciplina affine.
• Conoscenza base del ciclo di vita del medicinale e processo di submission regolatoria.
• Buone capacità analitiche, attenzione ai dettagli e organizzazione.

Responsibilities

• Supportare mappatura IDMP e analisi delle lacune in linea con EMA SPOR.
• Raccogliere, strutturare, validare e mantenere dati di prodotti medicinali.
• Contribuire alla preparazione di submission regolatorie strutturate.
• Supportare governance dati regolatori per qualità, coerenza e integrità.
• Collaborare con Regulatory Affairs per conformità e accuratezza.
• Sviluppare e migliorare processi, template e strumenti per submissions strutturate.

Skills

Analytical skills

Attention to detail

Organizational skills

Microsoft Excel

IDMP data concepts

SPOR understanding

Education

Laurea in Farmacia, Chimica Farmaceutica e Tecnologia (CTF)

Laurea magistrale in Regulatory Affairs

Tools

Microsoft Excel

Job description

Overview

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 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