Regulatory specilist
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 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.
KeyResponsibilitiesSupport 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.
RequirementsDegree 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.
BenefitsPermanent 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 benefitsStructured 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.
Job InformationIndustry Consulting
Job Type
Tempo pieno Salary 26.000 Work Experience 1-3 years Date Opened 19/10/2026 City Milano or Verona Province Lombardia Country Italy Postal Code 20122
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.
KeyResponsibilitiesSupport 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.
RequirementsDegree 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.
BenefitsPermanent 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 benefitsStructured 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.
Job InformationIndustry Consulting
Job Type
Tempo pieno Salary 26.000 Work Experience 1-3 years Date Opened 19/10/2026 City Milano or Verona Province Lombardia Country Italy Postal Code 20122