Regulatory specilist

We are seeking a Junior
Regulatory Specialist to join our Regulatory Affairs team.

The successful candidate
will 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 services
and international regulatory requirements.

Key
Responsibilities

• Support IDMP data
  mapping and gap analysis activities in alignment with EMA SPOR services
  and regulatory requirements.
  
• Assist in the
  collection, structuring, validation, and maintenance of medicinal product
  data from internal regulatory systems (e.g., RIM platforms and databases).
  
• Contribute to the
  preparation of high-quality, structured regulatory submissions.
  
• Support regulatory
  data governance initiatives to ensure data quality, consistency, and
  integrity.
  
• Collaborate with the
  Regulatory Affairs team to maintain regulatory compliance and data
  accuracy.
  
• Participate in the
  development and continuous improvement of processes, templates, and tools
  supporting structured data submissions.
  
• Assist in the
  preparation of documentation, guidance documents, and training materials
  related to IDMP, SPOR, and regulatory compliance.
  
• Contribute to
  cross-functional projects aimed at enhancing regulatory digitalization and
  data management practices.
  

Requirements

• Degree in Pharmacy, Pharmaceutical Chemistry and Technology
  (CTF), Biology, Biotechnology, Life Sciences, or a related scientific
  discipline.
  
• A Master's degree in
  Regulatory Affairs is considered 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 the digitalization of
  regulatory processes.
  
• Strong analytical
  skills and attention to detail.
  
• Excellent
  organizational and prioritization skills.
  
• Proficiency in Microsoft Excel.
  

Benefits

• Permanent employment contract. Hybrid working model.
  
• Classification under
  the Italian National Collective Labour Agreement (CCNL Commercio) 
  
• Annual gross salary
  (RAL) between €25,000 and €30.000 based on experience and
  qualifications.
  
• Employee benefits
  
• Structured training
  and professional development path.
  
• Opportunity to
  participate in innovative digital transformation projects within the Life
  Sciences sector.
  
• A collaborative,
  dynamic, and growth-oriented working environment.