At STADA we pursue our purpose “Caring for people‘s health as a trusted partner” worldwide. Originally founded by pharmacists, we are a leading manufacturer of high-quality pharmaceuticals. More than 12,300 employees around the globe live our values Integrity, Entrepreneurship, Agility and One STADA to achieve ambitious goals and shape the successful future of STADA.

EG is a part of the STADA Group and we take care for italian people's health since 1998.
High production standards, ethical and sustainable development models, professional support to doctors and pharmacists and high training of our Field Forces are among the key factors of our success. These factors have led us to be a leading company in the Italian market of generic drugs and an active company in biosimilars, hospital-medicines and OTC.
For our offices in Milan we are looking for

Regulatory Affairs Officer

We are looking for a Regulatory Affairs Officer. The candidate will support regulatory activities related to the management and maintenance of marketing authorization dossiers,



working closely with different company functions, external consultants, and the Pharmacovigilance team, providing support for activities related to the safety of medicinal and non-medicinal products.

Key Responsibilities
- Regulatory review of artworks and management of packaging and leaflet updates in accordance with approved texts and applicable regulations.
- Monitoring publications and updates issued by AIFA, EMA, and the Italian Official Gazetta(Gazzetta Ufficiale).
- Supporting the management and maintenance of registration dossiers and the preparation of documentation required by the Authorities.
- Managing regulatory activities related to non-pharmaceutical products and updating regulatory databases, electronic archives, and tracking systems.
- Submission of advertising and scientific information materials and use of the main AIFA portals.

Requirements
- Experience in Regulatory Affairs within the pharmaceutical

📌 Regulatory Affairs Officer (Milano)
🏢 STADA Arzneimittel
📍 Milano