Regulatory specilist

Arithmos S.r.l.; Veneto; On-site; EUR 25,000 - 30,000; Full time

Benefits offered by this job

Employee benefits

Training program

Job summary

Arithmos S.r.l. in Italy is seeking a Junior Regulatory Specialist to join the Regulatory Affairs team and support IDMP integration into regulatory processes.

You will assist in data governance, data quality, and lifecycle management in alignment with EMA SPOR services and international requirements. A strong foundation in regulatory affairs is essential for success.

Qualifications

• Degree in Pharmacy, Pharmaceutical Chemistry and Technology or Life Sciences.
• Master's in Regulatory Affairs is advantageous.
• Interest in Regulatory Affairs and pharma compliance.
• Understanding of medicinal product lifecycle and regulatory submissions.
• Interest in regulatory data management and digitalization.
• Strong analytical skills and attention to detail.
• Excellent organizational and prioritization skills.

Responsibilities

• Support IDMP datamapping and gap analysis in line with EMA SPOR and regulatory requirements.
• Assist collection, structuring, validation, and maintenance of medicinal product data.
• Contribute to the preparation of high-quality, structured regulatory submissions.
• Support regulatory data governance for data quality, consistency, and integrity.
• Collaborate with Regulatory Affairs to ensure compliance and data accuracy.
• Participate in development and improvement of processes, templates, and tools for data submissions.
• Assist in preparing documentation, guidance, and training on IDMP, SPOR, and regulatory compliance.
• Contribute to cross-functional projects enhancing regulatory digitalization and data management.

Skills

Analytical skills

Attention to detail

Organizational skills

Prioritization

Excel proficiency

Education

Bachelor or Master in Pharmacy/Pharmaceutical Sciences or Life Sciences

Master's in Regulatory Affairs (advantage)

Tools

Microsoft Excel

Job description

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.