Regulatory specilist

Job Information

• Industry Consulting
• Job Type Full time
• Salary 26.000
• Work Experience 1-3 years
• Date Opened 19/10/2026
• City Milano or Verona
• Province Lombardia
• Country Italy
• Postal Code 20122

About Us

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 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.