pAt 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. /p pbEG /b is a part of the STADA Group and we take care for italian people's health since 1998.br/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.br/For our offices in Milan we are looking for /p h3Regulatory Affairs Officer /h3 pWe are looking for a bRegulatory Affairs Officer /b. 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. /p h3Key Responsibilities /h3 ul liRegulatory review of bartworks /b and management of packaging and leaflet updates in accordance with approved texts and applicable regulations. /li liMonitoring publications and updates issued by bAIFA, EMA, and the Italian Official Gazetta(Gazzetta Ufficiale) /b. /li liSupporting the management and maintenance of bregistration dossiers /b and the preparation of documentation required by the Authorities.



/li liManaging regulatory activities related to bnon-pharmaceutical products /b and updating regulatory databases, electronic archives, and tracking systems. /li liSubmission of advertising and scientific information materials and use of the main AIFA portals. /li /ul h3Requirements /h3 ul liExperience in bRegulatory Affairs within the pharmaceutical industry /b, gained through the management of bprescription medicines /b. /li liExperience with bOTC and/or Consumer Healthcare (CHC) products /b will be considered a strong asset, demonstrating familiarity with different product categories and their respective regulatory requirements. /li liPrevious exposure to bPharmacovigilance activities /b will be considered an advantage, as will a genuine willingness to collaborate with this function and progressively expand expertise in this area. /li liThe ideal candidate is detail-oriented, well-organized, compliance-focused, able to work independently, and comfortable working in a cross-functional environment. /li /ul h3How We Take Care of Our People /h3 pOur Purpose, "Taking care of people's health as a trusted partner," guides our daily actions, including how we support our employees. We offer: /p ul liWellbeing initiatives and mental health support for all employees and their families, including access to the Kyan Health app. /li liA continuous learning environment through our free e-learning platform and a language-learning platform available to all employees. /li liA Growth Culture and objectives aligned with our Purpose. /li /ul pAre you looking for new challenges where you can make a difference for people's health? We are looking for candidates with expert knowledge and an entrepreneurial spirit that enjoy working collaboratively in a global team. /p #J-18808-Ljbffr

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