PpDirect message the job poster from Jefferson Wells Italia /p h3SCOPO DEL RUOLO: /h3 pResponsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with particular reference to EU. This role involves preparing regulatory dossiers, coordinating with health authorities, ensuring product registration, and providing regulatory guidance to cross‑functional teams. /p h3Regulatory Submissions Documentation: /h3 ul liPrepare, compile, and submit global regulatory dossiers for new marketing authorization applications (MAAs), variations, renewals. /li liEnsure timely and accurate submission of documents in compliance with global regulations. /li liSupport the labelling and change control processes to ensure timely and comprehensive review and approval of all packaging components (e.g., cartons, labels, Physicians Insert, Patient Insert, and Medical Guides). /li liMaintain high‑quality regulatory documentation, ensuring it is consistent, accurate, and compliant with regulatory requirements in different regions. /li /ul h3Regulatory Compliance Strategy: /h3 ul liSupport the development and implementation of global regulatory strategies for assigned products in collaboration with internal teams. /li liMonitor regulatory changes and industry trends to ensure compliance with evolving guidelines and support the updating of regulatory strategies. /li liAdvise cross‑functional teams (RD, Quality Assurance, Manufacturing, etc.) on regulatory requirements and strategies for market approval / lifecycle management. /li liContribute to the creation and maintenance of the Regulatory Affairs quality system, collaborating to the definition of processes and implementation of global standard procedures. /li liMaintain knowledge of global regulatory requirements and trends, sharing relevant updates with internal teams. /li liContribute to regulatory intelligence activities and provide insights into global regulatory landscape developments. /li liTrack regulatory submissions, approvals, and regulatory activities using tracking systems and ensure timely reporting to management. /li /ul h3Requisiti: /h3 ul liGood knowledge of EMA, ICH and FDA regulations, guidelines, and regulatory processes regarding drug development, approval, and maintenance of marketing authorisations. /li liStrong organisational skills; good commercial and product awareness. /li liSound administrative and systems background. /li liMinimum 3 years of experience in Regulatory Affairs in the Pharmaceutical Industry. /li liMaster Degree in scientific subject, preferable in Pharmacy or related. Master in Regulatory Affairs is considered a plus. /li liFluent in English, spoken and written. /li liMaster of Office. /li liFamiliarity with eCTD submission, compilation and publishing using specific tools. /li /ul h3Seniority level /h3 ul liAssociate /li /ul h3Employment type /h3 ul liFull‑time /li /ul h3Job function /h3 ul liPublic Relations, Writing/Editing, and Accounting/Auditing /li /ul h3Industries /h3 ul liHuman Resources, Pharmaceutical Manufacturing, and Research Services /li /ul /p #J-18808-Ljbffr