Regulatory Affairs Manager

ppWe are looking for a bRegulatory Affairs Manager /b to join our bRegulatory Affairs Team. /b /p h3WHAT WILL YOU DEAL WITH? /h3 h3Strategic Regulatory activities: /h3 ul liSupporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets. /li liProviding strategic guidance to clients on regulatory requirements and potential risks, ensuring compliance with EU and international frameworks. /li /ul h3Regulatory Affairs activities: /h3 ul liPreparing, reviewing, and overseeing bregulatory documentation /b for Marketing Authorization Applications (MAA), including CTD Modules. /li liEnsuring baccuracy, completeness, and consistency /b of regulatory submissions, in line with international guidelines and client requirements. /li liPlanning, coordinating, and managing bregulatory procedures /b (e.g. MAA, variations, line extensions, renewals) across EU and non‑EU markets. /li liProviding bregulatory support to clinical development and CMC projects /b, ensuring alignment with overall development plans. /li libCoordinating multidisciplinary teams and managing timelines /b to ensure high-quality deliverables and compliance with deadlines. /li liSupporting clients in regulatory decision-making through a brisk‑benefit approach. /b /li /ul h3WHAT ARE THE REQUIREMENTS? /h3 ul liMaster’s degree in bPharmaceutical Chemistry and Technology, Pharmacy, or related scientific fields. /b /li liAt least b5 of experience /b in Regulatory Affairs within the pharmaceutical sector. /li liStrong bknowledge of EU and international regulatory frameworks /b (EMA, FDA, ICH), with experience managing multi‑country projects. /li liExcellent command of bEnglish /b, both written and spoken. /li liStrong bproject management /b skills, excellent bcommunication /b abilities, and a bteam oriented mindset /b, with the capacity to coordinate complex projects, facilitate stakeholder dialogue, and collaborate effectively within multidisciplinary teams. /li libCCNL /b Commercial Sector /li libType of contract: /b permanent /li libSalary range (RAL): /b €40,000 – €45,000. The actual compensation offered may vary based on several factors, including job-related qualifications such as knowledge, skills, education, experience, and location. /li libBirthday leave /b /li libBuddy program /b for onboarding: from day one, you’ll be supported by a dedicated contact to help you settle in and integrate with the team /li /ul pThe selection, respects Legislative Decree 198/2006 and is open to candidates of any orientation or expression of gender, sexual orientation, age, ethnicity and religious belief. This announcement is designed to respect diversity and inclusiveness. /p /p #J-18808-Ljbffr