Senior Regulatory Affairs Consultant
20 ore fa
When our values align, there's no limit to what we can achieve. We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams. The role can be home or office based in various European locations. Key Responsibilities EU Product Information Management : Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements Serve as the key point of contact for EU Product Information for both internal and external stakeholders Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs Deliver competitive labelling searches and contribute to TCLP for early development assets Operational Excellence : Ensure timely tracking and management of all EU Product Information in appropriate systems Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports Coordinate Linguistic Review processes with LR Coordinator according to SOPs Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes Leadership & Collaboration : Lead the Local Labelling Committee for creation, review and approval of EU Product Information Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements Qualifications & Skills required for the role : University degree in a life science discipline Strong knowledge of EU regulatory requirements for product labelling and promotional materials Experience with electronic content management systems and regulatory SOPs Excellent project management and organizational abilities Outstanding written and verbal communication skills Proven ability to work effectively in cross-functional teams Fluent in English, written and spoken #J-18808-Ljbffr
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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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Senior Regulatory Affairs Consultant – Remote, Global
4 settimane fa
WorkFromHome, Italia Pqe Group A tempo pienoUna società di consulenza nel settore farmaceutico è alla ricerca di un Senior Regulatory Affairs da inserire nel suo team. Il candidato ideale ha almeno 5 anni di esperienza in ambito Regulatory Affairs, una laurea in una disciplina scientifica e una solida conoscenza delle normative e linee guida EU. Offriamo un contratto a tempo indeterminato, una...
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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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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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Senior Regulatory Affairs Specialist
4 giorni fa
WorkFromHome, Italia ACARPIA Farmaceutici S.r.l. A tempo pienoRegulatory Affairs Senior Specialist – ACARPIA Farmaceutici ACARPIA Farmaceutici è alla ricerca di una figura da inserire nel proprio team come Regulatory Affairs Senior Specialist. Il candidato sarà coinvolto in tutti gli aspetti del processo di registrazione e mantenimento dell’autorizzazione all’immissione in commercio (AIC) tramite rinnovi,...
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Senior Regulatory Affairs Strategist
20 ore fa
WorkFromHome, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve. Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining...
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Regulatory Affairs Specialist
20 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 Specialist — Remote Projects
4 settimane fa
WorkFromHome, Italia PQE Group A tempo pienoUna società di consulenza farmaceutica cerca un Senior Regulatory Affairs con 5-7 anni di esperienza. Il ruolo richiede la gestione delle attività regolatorie e la preparazione di dossier per le autorità competenti. Si richiede laurea in disciplina scientifica e competenze nel settore normativo europeo, inclusa la capacità di redigere dossier regolatori....
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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...
