Regulatory Affairs Manager

1 giorno fa


Rome, Italia IQVIA A tempo pieno
Per l’area CSO (Contract Sales Organization) ricerchiamo un/una Regulatory Affairs Manager.La risorsa prenderà in gestione principalmente le attività di stampo regolatorio e medico in relazione a un portafoglio prodotti variegato in area Specialty e Retail per un’azienda multinazionale leader.ResponsabilitàSupervisione regolatoria sull’attività di produzione materiali per la promozione medico-scientifica (materiale promozionale e di disease awareness)Gestione a tuttotondo del servizio medico-scientifico: dal supporto al team Marketing nella creazione dei contenuti fino alla revisione del materiale finale (definendo i perimetri regolatori previsti)Gestione delle sottomissioni regolatorie dei materiali comunicativi ad AIFA

in compliance con i requisiti normativi e con interazione diretta con i relativi funzionari– fungendo da punto di contatto principale tra l'azienda e le autorità regolatorie, gestendo le comunicazioni e rispondendo alle richieste di informazioniCollaborazione con il referente del servizio medico-scientifico IQVIA per la gestione di tutte le attività afferenti a tale responsabilità, compresa la stesura e l’aggiornamento delle SOP nonché il mantenimento del relativo sistema di qualitàMonitoraggio post-marketing: gestione delle attività di sorveglianza post-marketing per monitorare la conformità alle normative in ambito promozionaleFormazione del personale: organizzazione e conduzione di sessioni di formazione per la field-force relativamente a normative,

procedure di conformità e contenuti medico-scientifici di prodotto.Requisiti Laurea in discipline scientifiche (CTF, Farmacia, Medicina e Chirurgia)Esperienza di 6-8 anni in Dipartimenti di Regulatory Affairs/Servizio Scientifico di aziende farmaceutiche o società di consulenza regolatorieConoscenza della normativa e delle procedure regolatorie italiane ed europee in materia di medicinali e codici deontologiciPrecisione, accuratezza e cura dei dettagliEccellenti capacità organizzative e rispetto delle scadenze definiteCapacità di lavorare sia in team che in autonomiaAlta dose di flessibilità, dinamicità e buona capacità di adattamentoBuone capacità comunicative sia scritte che verbaliOttimo inglese, sia scritto che orale (costante necessità di relazione con interlocutori Global)Sede di lavoro: MilanoIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at SummaryLocation: Milan, ItalyType: Full time

  • Rome, Italia IQVIA A tempo pieno

    Per l’area CSO (Contract Sales Organization) ricerchiamo un/una Regulatory Affairs Manager.La risorsa prenderà in gestione principalmente le attività di stampo regolatorio e medico in relazione a un portafoglio prodotti variegato in area Specialty e Retail per un’azienda multinazionale leader.ResponsabilitàSupervisione regolatoria sull’attività di...


  • Rome, Italia Meditrial Europe Ltd. A tempo pieno

    Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs, and market access. Our offices are located in Germany, Italy, Switzerland, the UK, and the United States, and our teams rely on digital tools to work collaboratively to achieve shared goals.Since 2008, Meditrial...


  • Rome, Italia Meditrial Europe Ltd. A tempo pieno

    Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs, and market access. Our offices are located in Germany, Italy, Switzerland, the UK, and the United States, and our teams rely on digital tools to work collaboratively to achieve shared goals.Since 2008, Meditrial...


  • Rome, Italia Perrigo A tempo pieno

    Description Overview In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products in Consumer Healthcare, Medicinal Products, Food Supplements Scope of the Role Regulatory Affairs • Prepare applications and technical files in support of existing commercial product regulatory...


  • Rome, Italia Perrigo A tempo pieno

     At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the...


  • Rome, Italia Merck A tempo pieno

    Work Your Magic with us!Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...


  • Rome, Italia Alibaba A tempo pieno

    Basic InformationDepartment: Alibaba GroupDegree: BachelorWork Experience: 10 yearsJob DescriptionThe Senior Manager for Government Affairs will report directly to the Head of Alibaba International Government Affairs and will be based in Rome. The successful candidate will manage all regulatory, government, and political matters at the Italian and Balkian...


  • Rome, Italia Alibaba A tempo pieno

    Basic InformationDepartment: Alibaba GroupDegree: BachelorWork Experience: 10 yearsJob DescriptionThe Senior Manager for Government Affairs will report directly to the Head of Alibaba International Government Affairs and will be based in Rome. The successful candidate will manage all regulatory, government, and political matters at the Italian and Balkian...

  • Public Affairs Manager

    4 settimane fa


    Rome, Italia Pharmalex A tempo pieno

    We are growing, grow with us! Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then, PharmaLex is your career choice! PharmaLex is part of Cencora – the leading service provider for the pharmaceutical, biotech, and medical device industries globally. PharmaLex is specialised in effectively...

  • Public Affairs Manager

    4 settimane fa


    Rome, Italia PharmaLex GmbH A tempo pieno

    We are growing, grow with us!Are you eager to work in a dynamic company where new challenges and opportunities are part of your everyday life? Then, PharmaLex is your career choice!PharmaLex is part of Cencora – the leading service provider for the pharmaceutical, biotech, and medical device industries globally. PharmaLex is specialised in effectively...


  • Rome, Italia Radarconsulting A tempo pieno

    Siamo alla ricerca di un/una Regulatory Affairs ProjectManager da inserire in un’importante azienda internazionale leader nelsettore healthcare. L’azienda opera con successo nei mercati globali, offrendoprodotti innovativi e di alta qualità nei settori farmaceutico, degliintegratori alimentari, dei dispositivi medici, dei biocidi e dei cosmetici....

  • Sustainable Development

    2 settimane fa


    Rome, Italia Birra Peroni A tempo pieno

    What You’ll Be DoingWe are looking for a person who wants to undertake a professional path starting from the role of Sustainable Development & Corporate Affairs Expert.You will be included in the Corporate Affairs Team, reporting directly to the Sustainable Development Manager, with the aim of supporting the implementation and integration of sustainable...

  • Sustainable Development

    3 settimane fa


    Rome, Italia Birra Peroni A tempo pieno

    What You’ll Be DoingWe are looking for a person who wants to undertake a professional path starting from the role of Sustainable Development & Corporate Affairs Expert.You will be included in the Corporate Affairs Team, reporting directly to the Sustainable Development Manager, with the aim of supporting the implementation and integration of sustainable...


  • Rome, Italia Apple Inc. A tempo pieno

    Imagine what you could do here. At Apple, great ideas have a way of becoming great products, services, and customer experiences very quickly. Bring passion and dedication to your job and there’s no telling what you could accomplish. The Government Affairs Manager will help develop and implement policy advocacy strategy on a range of issues in Italy,...


  • Rome, Italia Pfizer A tempo pieno

    Inflammation&Immunology (I&I) Medical Affairs Scientist Line Manager, Specialty Care Specialty Care (SC) Medical Affairs colleagues are experts with a deep knowledge of their therapeutic area and their medicines. Physicians and other health care professionals and stakeholders view them as peers, and SC colleagues as partners. In Specialty Care Medical...


  • Rome, Italia Randstad A tempo pieno

    Randstad inhouse services, specialty pharma, is looking for a resource on behalf of Pfizer srl to be included in the Rome office in the role of External Supply Operations Quality Manager. Responsibilities:- The ESOQ Manager is accountable for providing quality assurance management of keycontractors for Pfizer and for assuring that the products supplied to...


  • Rome, Italia EUSA Pharma A tempo pieno

    Job PurposeOversee the development and implementation across the two BUs of the publication plans for global and local clinical studies and non-clinical trial sources, including HEOR, Epidemiology, RWE, Payer, non-Interventional and database studies, ensuring compliance with regulatory guidelines and industry standards. Manage the effective preparation,...


  • Rome, Italia Tesla A tempo pieno

    Job CategoryEnergy - Solar & StorageLocationMilan, MilanoReq. ID229503Job TypeFull-timeWhat to ExpectTesla is seeking an all-round public policy and business development manager to join its growing Energy EMEA team. This role can be based out of Madrid, Milan or Rome. In this role, you will play a critical role in in shaping and influencing the...


  • Rome, Italia Arrow Electronics, Inc. A tempo pieno

    Key Account Manager, Commercial Italy Campania RegionCSL SeqirusResponsible for developing long-term stakeholders’ relationships for the Campania region. Contacts potential key decision makers, works with regional agencies, health authorities, payors, group purchasing organizations, pharmacy associations, medical associations, hospital systems, KOLs and...


  • Rome, Italia Ramboll A tempo pieno

    Job Description Do you want to push the boundaries of your profession and develop your excellence in an open, collaborative and empowering culture? Are you motivated by creating sustainable change that benefits society and nature? Are you a curious and open-minded person? Ramboll is seeking a highly motivated Manager to lead projects and tasks...