Regulatory Affairs Specialist
9 ore fa
Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for aREGULATORY AFFAIRS SPECIALISTWithin 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 RESPONSIBILITIESWithin 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 renewalsWorking 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 managementPreparation 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/iesPreparation and management of the paediatric application and relevant update, if anyApplication of the existing working flows and Company proceduresMonitoring and understanding of new RA regulations and guidelines for the area of responsibility.JOB REQUIREMENTSBachelor Degree in scientific environment, including, but not limited to, Pharmacy, Pharmaceutical Chemistry and Technology, Biology, Biotechnology, Chemistry, is mandatoryAt least 3 years of previous experience in an international regulatory affairs department for pharma productsFluent in English, both written and oraldynamic, proactive and willing-to-do profileExcellent interpersonal, organizational and communication skills, capability in working in a team and good problem-solving attitude.Regulatory Affairs Specialist • Firenze, Toscana#J-18808-Ljbffr
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Regulatory Affairs Specialist
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Firenze, Italia Orienta A tempo pienoOrienta Healthcare ricerca, per azienda farmaceutica toscana un REGULATORY AFFAIRS SPECIALIST. Il Regulatory Affairs Specialist sarà inserito all'interno dell'Ufficio Regulatory Affairs riportando al Regulatory Affairs Manager. Requisiti richiesti: - Laurea in CTF, Farmacia o Biologia. - Esperienza pregressa in azienda farmaceutiche o aziende di...
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Regulatory Affairs Specialist
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Firenze, Italia Manpower A tempo pienoTalent 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...
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Global Regulatory Affairs Specialist — EU
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Firenze, Italia Manpower A tempo pienoA leading recruitment agency is seeking a Regulatory Affairs Specialist in Florence, Tuscany. This role involves managing product registrations and lifecycle maintenance while collaborating with various internal and external teams. Candidates should have a Bachelor's in a scientific field, at least three years of experience in regulatory affairs, and fluent...
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| Quality & Regulatory Affairs Specialist | 138725 |
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Firenze, Provincia di Firenze, Italia ManpowerGroup A tempo pienoTalent 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...
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Regulatory Affairs Coordinator Central and Latin America
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firenze, Italia ManpowerGroup A tempo pienoTalent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for aRegulatory Affairs Central and Latin America CoordinatorAre 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...