Regulatory Affairs Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8fgdbi

We are looking for a 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. Cross‐functional & Project Management activities: * 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 teams. Contract details & benefits: * CCNL Commerc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8fgdbi