Regulatory Affairs Manager
Pubblicato il 01-08-2026 - Altro in Italia
We are looking for a Ha le carte in regola per avere successo? Le seguenti informazioni devono essere lette attentamente da tutti i candidati. Regulatory Affairs Manager to join our Regulatory Affairs Team. WHAT WILL YOU DEAL WITH? Strategic Regulatory activities: Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets. Providing strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks. Regulatory Affairs activities: Preparing, reviewing, and overseeing regulatory documentation for Marketing Authorization Applications (MAA), including CTD Modules. Ensuring accuracy, completeness, and consistency of regulatory submissions, in line with international guidelines and client requirements. Planning, coordinating, and managing regulatory procedures (e.g. MAA, variations, line extensions, renewals) across EU and non‐EU markets.
Providing regulatory support to clinical development and CMC projects , ensuring alignment with overall development plans. Coordinating multidisciplinary teams and managing timelines to ensure high-quality deliverables and compliance with deadlines. Supporting clients in regulatory decision-making through a risk‐vantaggi approach. WHAT ARE THE REQUIREMENTS? Master's degree in Pharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields. At least 5 of experience in Regulatory Affairs within the pharmaceutical sector. Strong knowledge of EU and international regulatory frameworks (EMA, FDA, ICH), with experience managing multi‐country projects. Excellent command of English , both written and spoken. Strong project management skills, excellent communication abilities, and a team oriented mindset , with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary t