Regulatory Affairs Professional
14 ore fa
When our values align, there's no limit to what we can achieve. We are seeking a dedicated Regulatory Affairs Labelling professional to join our growing team This role offers an opportunity to work with global labelling teams, ensuring regulatory compliance and supporting product labelling management across multiple regions. The role can be home or office based in various European locations. Role Responsibilities Support Global Labelling, Regulatory (Clinical / Safety), or Medical Writing teams for labelling updates Manage Company Core Datasheet (CCDS) implementation into labelling and artworks Identify triggers for CCDS updates and coordinate impact assessments for technical changes Apply knowledge of Safety Signal Management and its impact on labelling Navigate CCDS governance processes in pharmaceutical environments Understand Periodic Safety Update Reports (PSUR) and their potential impact on labelling Manage the relationship between labelling and artwork processes Implement regulatory processes required to update product labelling (various variation categories) Prepare Addendum to Clinical Overview (Module 2.5) to support labelling variations Apply regulatory requirements for labelling updates across different regions (EU, EAEU, US, APAC) Manage SmPC, PIL and QRD requirements, EU linguistic reviews, and translation activities Coordinate readability and PIL testing processes Review and approve consumer-facing materials in accordance with approved labelling Participate in promotion review committees and provide regulatory guidance for local markets Provide technical and business consulting services within area of expertise Complete activities within project scope, timeline, and objectives Skills and Experience required for the role University Degree in a Scientific or Technical Discipline Initial years of labelling / regulatory experience with global responsibilities Regulatory Operations (Submission management) experience Outstanding interpersonal and intercultural communication skills (written and verbal) Critical thinking and problem-solving abilities Fluent in English, written and spoken #J-18808-Ljbffr
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Regulatory Affairs Manager
1 settimana fa
WorkFromHome, Italia Cpl Life Sciences A tempo pienoManaging Consultant - Regulatory Affairs & Quality @ Cpl Life Sciences ob Title: European Regulatory Affairs Manager Location: Milan, Italy - Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is...
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Regulatory Affairs Specialist
13 ore fa
WorkFromHome, Italia JSB Solutions A tempo pienoGlobal Regulatory Affairs Specialist - Italia Join to apply for the Global Regulatory Affairs Specialist - Italia role at JSB Solutions 2 days ago Be among the first 25 applicants 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...
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Senior Regulatory Affairs Consultant
4 settimane fa
WorkFromHome, Italia Pqe Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti darà...
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Senior Regulatory Affairs consultant
4 settimane fa
WorkFromHome, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti...
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Category Regulatory Affairs Manager
5 giorni fa
WorkFromHome, Italia Perrigo Company plc A tempo pienoCategory Regulatory Affairs Manager – Perrigo Company plc Join to apply for the Category Regulatory Affairs Manager role at Perrigo Company plc. 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...
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EU Regulatory Affairs Manager, Rare Diseases
2 settimane fa
WorkFromHome, Italia Chiesi Farmaceutici S.p.A. A tempo pienoA leading pharmaceutical company in Parma is looking for a Regulatory Affairs professional. The role includes developing regulatory strategies for Emerging Markets and managing regulatory submissions. Candidates should have 3 to 5 years of experience in corporate regulatory affairs and hold a Life Science Degree. The company values its employees, offering...
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Regulatory Affairs Specialist
3 settimane fa
WorkFromHome, Italia JSB Solutions A tempo pienoJSB 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 (JSB.FRK.25.010) da inserire all’interno della propria divisione Regulatory Affairs . Chi siamo: con quattro sedi operative in Italia...
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Regulatory Affairs Specialist
13 ore fa
WorkFromHome, Italia JSB Solutions A tempo pienoJSB 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 (JSB.FRK.25.010) da inserire all’interno della propria divisione Regulatory Affairs . Chi siamo: con quattro sedi operative in Italia...
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REGULATORY AFFAIRS SPECIALIST
3 giorni fa
WorkFromHome, Italia Ecupharma Srl A tempo pienoPharma Point, per conto di Ecupharma, azienda farmaceutica con un solido portafoglio di prodotti nelle aree terapeutiche specialistiche del SNC, urologica e cardiovascolare, è alla ricerca di un / a : Regulatory Affairs Specialist. La figura sarà inserita nel team di Regulatory Affairs e risponderà direttamente al Head of RA. Responsabilità Mantenimento...
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Regulatory Affairs Specialist
2 settimane fa
WorkFromHome, Italia Adecco A tempo pienoAdecco LifeScience , divisione specializzata di Adecco Italia, per importante azienda farmaceutica ricerca un/a Regulatory Affairs Specialist . La figura, inserita all'interno del team Regolatorio, riporterà direttamente all'Head of Regulatory Affairs. Responsabilità Gestione strategica delle AIC : presidio dei rinnovi, variazioni e adeguamenti normativi...
