Regulatory Affairs Manager
4 giorni fa
Regulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy. Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap. Compile Global Registration File per product and customise/supplement in preparation of local submission where necessary. Communicate/collaborate with relevant interfaces e.g., In-Center Product Centers and Value Streams, SYSQARA Regulatory Affairs and Registration Centers of Verticals Home and CC&V. Perform site registrations. Provide regulatory design input as per available information from SYSQARA functions as well as submission strategy guidance to sustaining and development project teams in In-Center Value Streams to ensure creation of approval-relevant documents. Determine and maintain relevant criteria and on that basis assess design and process changes, initiate local evaluation of potential regulatory impact as appropriate, monitor local feedback. Support global agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified Body. Initiate production transfer after registration approval. Perform tasks relevant to the Quality Management System e.g., CAPA. Prepare regulatory documentation required for tender procedures. Requirements Completed studies in a scientific/technical field or comparable training with professional experience. Minimum 1 year of professional experience in the field of Regulatory Affairs, Quality Management or other related Research and Development functions. Languages English, written and oral, preferably competence level C1-2, minimum B2. German optional. J-18808-Ljbffr
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Regulatory Affairs Officer
5 mesi fa
Bardi, Italia Acs Dobfar A tempo pienoRegulatory Affairs Officer for Finished Dosage Forms Department: Regulatory Affairs Line/Hierarchical Manager (Job Title): Regulatory Affairs Director, Regulatory Affairs Manager Direct Reports (Job Title): Main Activities expected by the Job: Prepare and submit regulatory submissions to health authorities, including Abbreviated New Drug Applications...
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Regulatory Affairs Head
8 ore fa
Bardi, Italia Adh Personal Thüringen A tempo pienoWe are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head.Key Responsibilities:Lead and manage the Regulatory Affairs team, ensuring proper training and professional development.Supervise the preparation, updates, and submission of European and international regulatory dossiers.Define...
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Regulatory Affairs
2 mesi fa
Bardi, Italia Antal International Network A tempo pienoAntal International è una multinazionale dell'headhunting con più di 140 uffici in 40 paesi. Life science, Chemical and Food è un team specializzato in profili con background scientifico ed ingegneristico in ambito Manufacturing, Produzione, Ingegneria, SCM, Research and Development, Medico, Qualità e tecnico-commerciale nell'ambito Pharma, Chimico...
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Regulatory Affairs
1 mese fa
Bardi, Italia Antal International Network A tempo pienoAntal International è una multinazionale dell'headhunting con più di 140 uffici in 40 paesi.Life science, Chemical and Food è un team specializzato in profili con background scientifico ed ingegneristico in ambito Manufacturing, Produzione, Ingegneria, SCM, Research and Development, Medico, Qualità e tecnico-commerciale nell'ambito Pharma, Chimico...
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Regulatory Affairs Head
9 ore fa
Bardi, Italia Adh Personal Thüringen A tempo pienoWe are partnering with a leading Active Pharmaceutical Ingredients (API) manufacturing company to recruit a Regulatory Affairs Head. Key Responsibilities: Lead and manage the Regulatory Affairs team, ensuring proper training and professional development. Supervise the preparation, updates, and submission of European and international regulatory dossiers....
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Regulatory Affairs Manager
4 settimane fa
Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pienoRegulatory Affairs Manager (m/w/d)Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.TasksObtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.Compile Global Registration File...
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Cmc Regulatory Affairs Manager
3 settimane fa
Bardi, Italia Buscojobs A tempo pienoFondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases.For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...
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Regulatory Affairs Manager
1 mese fa
Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pienoRegulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap. Compile Global Registration...
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Regulatory Affairs Manager
4 settimane fa
Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pienoRegulatory Affairs Manager (m/w/d) Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.Tasks Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.Compile Global Registration File...
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Regulatory Affairs Manager
1 mese fa
Bardi, Italia Ch01 Che Fresenius Medical Care (Schweiz) Ag A tempo pienoRegulatory Affairs Manager (m/w/d)Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.TasksObtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap.Compile Global Registration File...
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Senior Regulatory Affairs Specialist
2 mesi fa
Bardi, Italia Page Personnel A tempo pienoRicerchiamo un profilo specializzato in ambito Regulatory Affairs nell'ambito dei principi attivi farmaceutici che, a riporto del Regulatory Affairs Manager, andrà ad occuparsi di gestione, aggiornamento e sottomissione puntuale della documentazione regolatoria dei prodotti nel portafoglio aziendale.Supporto ai vari dipartimenti aziendali e agli stakeholder...
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Senior Regulatory Affairs Manager
2 settimane fa
Bardi, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager / Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a...
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Regulatory Affairs Specialist
5 mesi fa
Bardi, Italia Antal International Network A tempo pienoAntal International è una multinazionale dell'headhunting con più di 140 uffici in 40 paesi.Life science, Chemical and Food è un team specializzato in profili con background scientifico ed ingegneristico in ambito Manufacturing, Produzione, Ingegneria, SCM, Research and Development, Medico, Qualità e tecnico-commerciale nell'ambito Pharma, Chimico...
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Regulatory Affairs Specialist
2 mesi fa
Bardi, Italia In Job S.P.A. A tempo pienoIn Job S.p.A. – Milan's Career Center is hiring a Regulatory Affairs Specialist for a lead company in the pharmaceutical industry. KEY RESPONSIBILITIES Support product development and manage registration and maintenance of new and/or existing products worldwide; Assist in updating and maintaining the Regulatory Information Management System (RIMS);...
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Junior Regulatory Affairs Specialist
8 ore fa
Bardi, Italia Air Liquide A tempo pienoAir Liquide Medical Systems srl, part of the Air Liquide Group, is the business line of the Air Liquide Healthcare Division dedicated to Medical Devices.Air Liquide Medical Systems deals with medical devices for the treatment of respiratory diseases. The company develops, manufactures and sells innovative products in three different areas of respiratory...
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Regulatory Affairs Officer
2 mesi fa
Bardi, Italia Antal International Network A tempo pienoSiamo alla ricerca di un/una REGULATORY AFFAIRS OFFICER per un'azienda cliente nel settore cosmetico.La persona si occuperà di:redazione della documentazione per l'ottenimento ed il mantenimento delle autorizzazioni all'ammissione in commercio dei prodotti cosmetici; gestione delle pratiche di registrazione presso le Autorità Regolatorie nazionali ed...
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Regulatory Affairs Officer
4 giorni fa
Bardi, Italia Antal International Network A tempo pienoSiamo alla ricerca di un/una REGULATORY AFFAIRS OFFICER per un'azienda cliente nel settore cosmetico. La persona si occuperà di: redazione della documentazione per l'ottenimento ed il mantenimento delle autorizzazioni all'ammissione in commercio dei prodotti cosmetici; gestione delle pratiche di registrazione presso le Autorità Regolatorie nazionali ed...
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Regulatory Affairs Intern Pavia
2 giorni fa
Bardi, Italia Biopharmed A tempo pienoBiopharmed: Life Sciences Recruiting**Posizione**:**Biopharmed **è l'agenzia di **head hunting** progettata per la ricerca e selezione di profili tecnici e specialistici del mondo **Life Sciences.****Posizione**:Ricerchiamo un **Regulatory Affairs Intern** per importante azienda operante nel settore dei pricipi attivi.**Principali responsabilità**:-...
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Corporate Regulatory Affairs Specialist
5 giorni fa
Bardi, Italia Flamma Spa A tempo pienoFlamma Group è un'azienda specializzata nello sviluppo, produzione e commercializzazione di molecole e principi attivi (API) per l'industria farmaceutica. Con Headquarter a Chignolo d'Isola, vicino a Milano, Flamma vanta altri due stabilimenti produttivi in Italia, ad Isso (BG) e Bulciago (LC) e due stabilimenti all'estero, a Philadelphia (USA) e Dalian...
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Regulatory Affairs Officer
2 mesi fa
Bardi, Italia Antal International Network A tempo pienoSiamo alla ricerca di un/una REGULATORY AFFAIRS OFFICER per un'azienda cliente nel settore cosmetico. La persona si occuperà di: redazione della documentazione per l'ottenimento ed il mantenimento delle autorizzazioni all'ammissione in commercio dei prodotti cosmetici; gestione delle pratiche di registrazione presso le Autorità Regolatorie nazionali ed...