Junior Regulatory Specialist - IDMP & Data Governance

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

Benefits offered by this job

Employee benefits

Structured training and professional发展

Job summary

Arithmos S.r.l. in Milano/Verona seeks a Junior Regulatory Specialist to support IDMP data mapping, governance, and lifecycle management in line with EMA SPOR standards and international regulatory requirements.

You will assist in high-quality submissions, data governance, and regulatory digitalization initiatives while gaining structured training and a clear development path in the Life Sciences sector.

Qualifications

• 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.

Responsibilities

• Support IDMP datamapping 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.

Skills

Analytical skills

Attention to detail

Organizational skills

Prioritization

MS Excel

Education

Degree in Pharmacy/Pharmaceutical Sciences

Master's in Regulatory Affairs (advantage)

Tools

RIM platforms

Job description

Arithmos S.r.l. in Milano/Verona seeks a Junior Regulatory Specialist to support IDMP data mapping, governance, and lifecycle management in line with EMA SPOR standards and international regulatory requirements.

You will assist in high-quality submissions, data governance, and regulatory digitalization initiatives while gaining structured training and a clear development path in the Life Sciences sector.