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 industry, gained through the management of prescription medicines.




- Experience with OTC and/or Consumer Healthcare (CHC) products will be considered a strong asset, demonstrating familiarity with different product categories and their respective regulatory requirements.
- Previous exposure to Pharmacovigilance activities will be considered an advantage, as will a genuine willingness to collaborate with this function and progressively expand expertise in this area.
- The ideal candidate is detail-oriented, well-organized, compliance-focused, able to work independently, and comfortable working in a cross-functional environment.

How We Take Care of Our People

Our Purpose, "Taking care of people's health as a trusted partner," guides our daily actions, including how we support our employees. We offer:

- Wellbeing initiatives and mental health support for all employees and their families, including access to the Kyan Health app.
- A continuous learning environment through our free e-learning platform and a language-learning platform available to all employees.
- A Growth Culture and objectives aligned with our Purpose.

📌 Regulatory Affairs Officer (Milano)
🏢 STADA
📍 Milano