Eu&Int Regulatory Affair Manager

1 settimana fa

LATINA, Italia Iqvia Italia A tempo pieno

On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a EU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic atmosphere.RESPONSIBILITIESDevelop regulatory strategies for the Emerging Markets countries to meet Chiesi Global Rare Diseases Regulatory Affairs relevant objectives, with regional Head limited supervisionIn collaboration with consultants, partners and affiliates, plan, coordinate and manage regulatory submissions to regional agencies throughout the life cycle of GRD productsIn full alignment with the regional Head, provide advice and guidance regarding regional regulatory requirements driving the development and geographical expansion of GRD products.Contribute to the preparation and / or review of submissions to relevant markets to ensure the high quality of the documentationIn agreement with the regional Head, communicate directly with regional regulatory authorities on behalf of Chiesi GRD to negotiate strategies and actions associated with regulatory submissionsCritically review regulatory submission documents, periodic updates, overviews, summaries, etc., make recommendations for improvement and ensure adequacy for submission.Contributes to the development of processes and the preparation of Standard Operating Documents for GRD Regulatory AffairsIn full alignment with the regional Head, provide regulatory guidance to colleagues from other functional areasProvide regulatory expertise in support of due diligence assessmentsRepresent the Regulatory Department at the Core Team as a global RA member, where neededSupport the Regional GRD Regulatory Affairs Head in the preparation of the needed documents for the meetings and interactions with regional regulatory authoritiesREQUIREMENTS AND SKILLSExperience required: 3 to 5 years of experience in corporate regulatory affairs roles with an in-depth knowledge in the drug developmentEducation: Life Science DegreesTechnical Skills: good levelSoft Skills:flexible, collaborative, open mindedWell-developed written and oral communication and listening skillsWell-developed time management skills and demonstrated ability to manage complex assignments.Experience in leadership and coaching is an asset.Well-developed analytical and problem-solving skills.Ability to work independently and as part of a team.TYPE OF CONTRACTChemical ContractIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request.Applications WITHOUT the requirements Will NOT be fully taken into#J-*****-Ljbffr

  • Eu&Int Regulatory Affair Manager

    1 settimana fa

    LATINA, Italia Iqvia Italia A tempo pieno

    On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a EU & INT Regulatory Affair Manager who can join an exciting working environment in a dynamic atmosphere....

  • Director Of Regulatory Affairs

    5 giorni fa

    LATINA, Italia Buscojobs IT C2 A tempo pieno

    The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations. Reporting to the VP of Clinical Quality and...

  • Regulatory Affairs Senior Officer

    2 settimane fa

    LATINA, Italia Randstad Italia Spa A tempo pieno

    Mansione Randstad Talent Selection, divisione di Randstad Italia specializzata nella Ricerca &, Selezione di candidati qualificati, ricerca per azienda chimico farmaceutica un REGULATORY AFFAIRS SENIOR OFFICER Si offre: inserimento a scopo assunzione a tempo indeterminato, Luogo di lavoro: Aprilia (LT) Responsabilit Compiti e responsabilit : - Predispone la...

  • Emea Regulatory Management Center Translation

    4 giorni fa

    Latina, Italia Johnson & Johnson A tempo pieno

    At **Janssen**, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can...

  • Quality and Regulatory Affairs Manager

    2 settimane fa

    Cisterna di Latina, Italia Wyser A tempo pieno

    Wyser è la società internazionale di Gi Group che si occupa di ricerca e selezione di middle e senior management specializzato.Facciamo parte di Gi Group, una delle principali realtà a livello internazionale nei servizi dedicati allo sviluppo del mercato del lavoro. Per importante azienda cliente operante nel settore Food & Beverage ricerchiamo...

  • Analista

    4 settimane fa

    Latina, Italia Public Affairs Advisors A tempo pieno

    Analyst – RomeThe Analyst will support the professionals of the firm in monitoring the legislative, regulatory and policy activity in the main Italian government bodies and regulatory authorities, as well as in the most relevant regions in Italy. The Analyst will develop analysis reports, memos and position papers aimed at the Clients of the firm, together...

  • Analista

    4 giorni fa

    Latina, Italia Public Affairs Advisors A tempo pieno

    Analyst – RomeThe Analyst will support the professionals of the firm in monitoring the legislative, regulatory and policy activity in the main Italian government bodies and regulatory authorities, as well as in the most relevant regions in Italy. The Analyst will develop analysis reports, memos and position papers aimed at the Clients of the firm, together...

  • AI Program Manager

    4 settimane fa

    Latina, Italia ESYEN A tempo pieno

    Are you an Artificial Intelligence professional with a passion for innovation? Do you excel at transferring knowledge, mentoring teams and scouting cutting-edge AI applications? Would you like to apply your AI expertise to Space, one of the fastest growing and most strategic industries in Europe? We are looking for a highly skilled AI Program Manager to join...

  • Store Manager

    7 giorni fa

    LATINA, Italia Etjca Group A tempo pieno

    Panoramica di PresentazioneIl nostro cliente è un'importante realtà internazionale, leader nel settore dell'abbigliamento e delle calzature sportive ad alte prestazioni, specializzata nello sviluppo di prodotti tecnici progettati per ottimizzare le performance atleticheJob Title e finalità di Ruolo: STORE MANAGERLa risorsa ideale è domiciliata nell'area...

  • Onsite Manager

    1 settimana fa

    LATINA, Italia Numen Spa A tempo pieno

    Sede di Lavoro Roma Cerchiamo un Site Manager per impianti meccanici per la gestione quotidiana del cantiere,specializzato in impianti meccanici hard - service da inserire con urgenza nella nostra DirezioneOperativa.Responsabilità:Coordinamento operativo: Gestire le attività quotidiane sul cantiere, dalla preparazione all'ultimazione dei lavori,...