Regulatory Affairs Specialist

3 giorni fa

Florence, Italia Manpower A tempo pieno

Talent Solutions , part of Manpower Group, for an important pharmaceutical client based in Florence , is currently recruiting for a REGULATORY AFFAIRS SPECIALIST Within the Global Regulatory Affairs department - EU and North America area (EUNA), we are looking for a Regulatory Affairs Specialist with a direct report to the EUNA Therapeutic Area Manager. The resource will be responsible of handling a specific portfolio of products, guaranteeing the obtainment of new registrations and/or the maintenance of the existing ones in the Region in scope. MAIN ACTIVITIES AND RESPONSIBILITIES Within the EUNA Regulatory Affairs team and under the guidance of the Therapeutic Area Manager, the resource will deal with the registrations and/or life cycle maintenance activities of the products in the specialty and primary care area. It will include, at least: • Planning/organizing activities for preparing new product registration and/or maintenance of the existing registration through variation procedures and renewals • Working in cooperation with technical internal functions (such as Quality Assurance, Medical, Marketing, Clinical, Pharmacovigilance), and local regulatory teams or external partners for the preparation of the regulatory application related to new registrations and/or lifecycle management • Preparation of the master data package to be shared with the local regulatory affairs contacts in order to proceed with the customization, as necessary, and submission of the application to the competent Authority/ies • Preparation and management of the paediatric application and relevant update, if any • Application of the existing working flows and Company procedures • Monitoring and understanding of new RA regulations and guidelines for the area of responsibility. JOB REQUIREMENTS Bachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatory At least 3 years of previous experience in an international regulatory affairs department for pharma products Fluent in English, both written and oral dynamic, proactive and willing-to-do profile Excellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude. Scientific degree; 3 years previous experience in pharmaceutical regulatory affairs; Fluency in English

  • Global Regulatory Affairs Specialist

    2 settimane fa

    Florence, Toscana, Italia JSB Solutions srl A tempo pieno

    JSB Solutions – azienda leader nei servizi life sciences con focus su consulenza, gestione studi clinici e sviluppo software – ricerca per il potenziamento del proprio organico una figura di Regulatory Affairs Specialist – Italia (JSB.SRF da inserire all'interno della propria divisione Regulatory Affairs.Chi siamo: con quattro sedi operative in Italia...

  • Global Regulatory Affairs Specialist

    4 giorni fa

    Florence, Toscana, Italia JSB Solutions A tempo pieno

    JSB Solutions– azienda leader nei servizi life sciences con focus su consulenza, gestione studi clinici e sviluppo software – ricerca per il potenziamento del proprio organico unGlobal Regulatory Affairs Specialist(JSB.SRF da inserire all'interno della propria divisioneRegulatory Affairs.Chi siamo:con quattro sedi operative in Italia (Firenze, Parma,...

  • Regulatory Affairs Administration Assistant_legge 68/99

    4 settimane fa

    Florence, Italia Randstad Italy A tempo pieno

    Randstad Talent Selection Hopportunities è la specialty che si occupa di Ricerca & Selezione di professionisti qualificati appartenenti alle categorie protette. Il nostro cliente è un'importante realtà internazionale e ci ha incaricato di ricercare la figura di Regulatory Affairs Administration Assistant_legge 68/99 (invalidità civile) Si offre un...

  • Global Regulatory Affairs Manager

    4 giorni fa

    Florence, Italy Metropolitan Area Hays A tempo pieno

    Responsabile Affari Regolatori - Dispositivi Medici - FDALa tua nuova aziendaIl nostro cliente è un'azienda multinazionale leader nel settore dei dispositivi medici elettromedicali. Con una forte presenza globale e un impegno costante nella ricerca e sviluppo, l'organizzazione offre prodotti e servizi ad alto contenuto tecnologico per supportare la salute e...

  • Regulatory Affairs Coordinator Central and Latin America

    2 settimane fa

    Florence, Italia ManpowerGroup A tempo pieno

    Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a Regulatory Affairs Central and Latin America Coordinator Are you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment...

  • Global Regulatory Affairs Operations Innovation and Information Management Senior Associate

    4 giorni fa

    Florence, Toscana, Italia Menarini A tempo pieno

    OverviewJoin our Global Regulatory Affairs Operations department as a Senior Associate in the Innovation and Information Management (IIM) area. Reporting to the IIM Manager, you will play a critical role in managing our core regulatory data and systems, ensuring global compliance, and driving the implementation of new technology solutions across the Menarini...

  • Content Management Specialist

    3 giorni fa

    Florence, Italia Manpower A tempo pieno

    Talent Solutions , part of Manpower Group, for an important pharmaceutical client based in Florence , is currently recruiting for a Global Regulatory Affairs Operations – Content Management Specialist The resource will join the Content Management team. In this role, the hired person will be instrumental in supporting the Content Management Manager and...

  • Global Regulatory Affairs Operations Innovation and Information Management Senior Associate

    4 giorni fa

    Florence, Toscana, Italia MENARINI Group A tempo pieno

    OverviewJoin ourGlobal Regulatory Affairs Operationsdepartment as a Senior Associate in the Innovation and Information Management (IIM) area. Reporting to the IIM Manager, you will play a critical role in managing our core regulatory data and systems, ensuring global compliance, and driving the implementation of new technology solutions across the Menarini...

  • Regulatory Affairs Central and Latin America Coordinator

    1 settimana fa

    Florence, Toscana, Italia MENARINI Group A tempo pieno

    OverviewAre you a highly motivated and detail-oriented regulatory professional looking to make a significant impact on a global scale? Do you thrive in a fast-paced environment where your expertise directly contributes to bringing life-changing products to market?Our Global Regulatory Affairs Department is seeking a dedicated individual to join our mission....

  • Medical Affairs Manager

    2 settimane fa

    Florence, Toscana, Italia Menarini A tempo pieno

    OverviewWe are looking for a highly strategic and medically grounded individual for a high-impact Medical Affairs Manager role. This position is central to ensuring our innovative portfolio in General Medicine & Specialty Care reaches all eligible patients.As the key medical-scientific expert, you will be responsible for promoting and preserving the value...