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

📌 Regulatory specilist (Milano)
🏢 Arithmos
📍 Milano