Regulatory Affairs Specialist
1 giorno fa
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. Regulatory Affairs Specialist • Firenze, Toscana #J-18808-Ljbffr
-
Regulatory Affairs Specialist
5 giorni fa
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...
-
Regulatory Affairs Specialist Medical Devices
2 settimane fa
Firenze, Italia GIGROUP A tempo pienoLa Divisione LifeScience di Gi Group (Agenzia per il Lavoro, Aut. Min. 26/11/04 Prot. n. 1101-SG), prima multinazionale italiana del lavoro, è specializzata nella Ricerca e Selezione di profili specializzati nei settori Farmaceutico e Medicale. In collaborazione con una importante realtà operante del settore dei Medical Devices e presente nel panorama...
-
Global Regulatory Affairs Specialist — EU
1 giorno fa
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...
-
Global Regulatory Affairs Specialist
3 giorni fa
Firenze, 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 un **Global Regulatory Affairs Specialist** _(JSB.SRF.24.081)_ da inserire all’interno della propria divisione **Regulatory Affairs**. **Chi siamo**: con quattro sedi operative...
-
Regulatory Affairs Consultant
2 settimane fa
Firenze, Italia Pharma D&S A tempo pienoPharma D&S ricerca un Regulatory Affairs Consultant con almeno 2/3 anni di esperienza nel ruolo: La risorsa selezionata si occuperà di: - Collaborare alla definizione della strategia regolatoria - Preparare la documentazione di Qualità (Modulo 3 e 2.3) - Preparare la domanda di deposito di un Master File della Sostanza Attiva (ASMF) - Preparare variazioni...
-
Stage Regulatory Affairs
2 settimane fa
Firenze, Italia Pharma D&S A tempo pienoPharma D&S offre a neolaureate/i che frequentano un Master di specializzazione in Affari Regolatori l'opportunità di completare il percorso formativo con un tirocinio curriculare retribuito. Eventuali esperienze all'estero, la capacità di lavorare in team e l'ottima conoscenza della lingua inglese saranno requisiti preferenziali nella...
-
Regulatory Affairs Consultant
2 settimane fa
Firenze, Italia JSB SOLUTIONS S.R.L A tempo pieno**JSB Solutions**, società di servizi nel settore Life Science che offre consulenza, gestione di studi clinici e sviluppo software, con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un** Regulatory Affairs Consultant** _(JSB.FRK.24.009) _da inserire all'interno della nostra divisione degli** affari regolatori.** - pianificazione e supporto...
-
| Quality & Regulatory Affairs Specialist | 138725 |
1 settimana fa
Firenze, Italia Orienta Agenzia Per Il Lavoro A tempo pienoOrienta SPA- Società benefit, filiale di Firenze, ricerca per azienda metalmeccanica operante nel settore biomedicale, specializzata nella progettazione e produzione di strumenti ad alta precisione un/unaQUALITY & REGULATORY AFFAIRS SPECIALISTResponsabilità principali:Monitorare e applicare in modo costante le normative di settore, le direttive comunitarie...
-
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...
-
Regulatory Affairs Coordinator Central and Latin America
3 settimane fa
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...
