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.

📌 Regulatory specilist (Milano)
🏢 Azienda Leader
📍 Milano