Lavori attuali relativi a Regulatory Affairs Specialist - Roma, Lazio - Human Value
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Page Personnel A tempo pieno**Job Summary**Page Personnel is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.**Key Responsibilities**Manage and prepare regulatory dossiers (CTD) for...
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno{"title": "Regulatory Affairs Manager", "company": "Meditrial Europe Ltd.", "location": "Rome, Italy", "job_type": "Full-time", "industry": "Lifescience", "function": "Regulatory Affairs", "responsibilities": ["Management of CTD (Electronic Common Technical Document)", "Collaboration during implementations of regulatory strategies for New MA through...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Page Personnel A tempo pienoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances in the US, EU, and extra-EU markets.Main Responsibilities:Managing and preparation of regulatory dossier (CTD)...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pienoJob DescriptionMeditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the life science industry. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements for products requiring governmental approval.Key Responsibilities:Manage...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pienoJob DescriptionMeditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the life science industry. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements for products requiring governmental approval.Key Responsibilities:Manage...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Abbott A tempo pienoJob Summary: Support the development of regulatory strategies for the registration and reimbursement of new products, ensuring alignment with business objectives and regulatory requirements. Maintain in-line products and monitor new regulations to support business growth. Assess the impact of upcoming regulations on products for external engagement through...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pienoJob DescriptionMeditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the lifescience industry. We are seeking a highly skilled Regulatory Affairs Manager to oversee the regulation process for products requiring governmental approval.Key Responsibilities:Regulatory Strategy...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Abbott A tempo pienoJob Summary: As a key member of the Abbott team, you will play a crucial role in supporting the registration and reimbursement of new products, ensuring alignment with business strategy and regulatory requirements. Your expertise will be essential in maintaining in-line products and monitoring new regulations to drive business growth.Core...
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Regulatory Affairs Specialist
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Roma, Lazio, Italia Abbott Laboratories A tempo pienoJob Summary:Support the development and implementation of regulatory strategies for the registration and reimbursement of new products at Abbott Laboratories, ensuring alignment with business objectives and regulatory requirements. Monitor new regulations and maintain in-line products to support business growth. Assess the impact of upcoming regulations on...
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Regulatory Affairs Expert
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Roma, Lazio, Italia Eli Lilly and Company A tempo pienoJob SummaryWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Eli Lilly and Company. As an Associate Director/Director, GRA-EMEA, you will be responsible for establishing local regulatory strategies and plans for assigned products in the region/country, ensuring alignment with global regulatory strategies and incorporating local...
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Roma, Lazio, Italia Synergie Filiale di Pomezia A tempo pienoCompany: Synergie Filiale di PomeziaPosition OverviewWe are seeking a dedicated professional to join our Regulatory Affairs team within the Nutrition division of a prominent American multinational operating in the Pharmaceutical and Medical Device sectors.Key ResponsibilitiesThe selected candidate will be integrated into the Regulatory Affairs Office,...
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Regulatory Compliance Manager
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Roma, Lazio, Italia Page Personnel A tempo pienoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Key ResponsibilitiesManage and prepare regulatory dossiers (CTD) for...
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Medical Affairs Specialist
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Roma, Lazio, Italia Dompe A tempo pienoJob Title: Medical Affairs ExpertJoin Dompe as a Medical Affairs Expert and contribute to the advancement and innovation of our products in the assigned therapeutic area.About the Role:We are seeking a highly skilled Medical Affairs Expert to support the Medical Affairs Department in developing and conducting scientific projects. The ideal candidate will...
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Regulatory Affairs Manager
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Roma, Lazio, Italia Elanco A tempo pienoJob Title: Regulatory Affairs ManagerAt Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the...
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Regulatory Operations Specialist
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Roma, Lazio, Italia Randstad A tempo pienoRegulatory Operations AssociateRandstad Inhouse Services is seeking a skilled Regulatory Operations Associate to support Pfizer srl's regulatory team. The successful candidate will be responsible for managing regulatory change activities for products manufactured by External Supply Quality (ESQ) managed contractors.Key ResponsibilitiesInitiate, review, and...
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Regulatory Operations Specialist
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Roma, Lazio, Italia Randstad A tempo pienoRandstad Inhouse Services, a leading provider of specialized staffing solutions, is seeking a skilled professional to join the regulatory team as a Contractor Regulatory Operations Associate. This role will be responsible for managing regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ)...
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Global Regulatory Affairs Specialist
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Roma, Lazio, Italia Elanco A tempo pienoJob Summary:This role contributes to the regional registration activities for new and existing products by planning, coordinating, and delivering registration documentation to the regulatory agencies for assigned portfolio of products registered in two or more EEA countries (or the UK).Key Responsibilities:Support submission preparation in execution of...
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Medical Affairs Specialist
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Roma, Lazio, Italia Pfizer, S.A. De C.V A tempo pieno{"title": "Medical Affairs Specialist", "subtitle": "Rare Hematology Expert", "content": "Pfizer, S.A. De C.V is seeking a Medical Affairs Specialist to join our team in Italy. As a key member of our Specialty Care Medical Affairs organization, you will be responsible for Rare Hematology diseases in Italy.Key Responsibilities:Support scientific congresses,...
Regulatory Affairs Specialist
3 mesi fa
- Dicofarm opera su tutto il territorio nazionale con la propria rete di informatori medico scientifici e i suoi prodotti vengono altresì commercializzati, con marchi propri o di terzi, per effetto di accordi di co-marketing, in altri Paesi europei.
- Attraverso l'investimento nelle risorse umane e alla continua ricerca dell'innovazione Dicofarm sviluppa e distribuisce i suoi prodotti per la cura del bambino nell' area della Pediatria**Siamo alla ricerca di un/una**
**Regulatory Affairs Specialist**
**Il Ruolo**: La persona, rispondendo direttamente al Chief Medical Officer, si occuperà di:
- Gestire gli affari regolatori e gli aggiornamenti normativi del farmaco
- Redigere ed implementare la documentazione técnica del farmaco (CTD, PSF, IMPD, etc...) per le sottomissioni regolatorie verso le autorità competenti;
- Gestione del processo delle attività regolatorie del farmaco (domande AIC, rinnovi, variazioni, trasferimenti etc.) e l'allestimento di pratiche regolatorie da sottomettere ad AIFA;
- Gestione degli aspetti regolatori durante ispezioni da parte di Autorità Competenti(farmaci)
**Attività di supporto**:
- Coadiuvare la gestione delle attività di vigilanza e sorveglianza post-marketing in ambito dei dispostivi medici
- Coadiuvare gli affari regolatori e gli aggiornamenti normativi dei dispositivi medici
- Coadiuvare la stesura e l'aggiornamento dei fascicoli tecnici per i dispositivi medici secondo MDD 93/42/EEC e MDR 2017/745 e sovraintendere le relazioni con organismi notificati;
- Coadiuvare la stesura del testo delle istruzioni d'uso e del materiale promozionale dei dispositivi medici
- Supporto sugli aspetti regolatori durante audit di sorveglianza da parte dell'ON (medical devices)
**Stakeholder**:
- **Interni**: ufficio regolatorio, ricerca clinica, medical affairs
- **Esterni**: autorità competenti, organismi notificati, consulenti specializzati
**I Requisiti**:
- Laurea in discipline scientifiche
- 5/7 anni di esperienza pregressa presso azienda farmaceutica e/o del settore degli integratori alimentari e dei dispositivi medici
- Conoscenza normative di settore in ambito regolatorio (farmaci e dispositivi medici)
- Conoscenza degli standards ISO 9001 e ISO 13485, GMP, GVP, GCP
- Almeno 5 anni di esperienza lavorativa in ambito Regolatorio del farmaco maturata in aziende farmaceutiche. Auspicabile ma non vincolante esperienza nell'ambito dei dispositivi medici a base di sostanze.
- Buona conoscenza dei principali software applicativi MS Office (Word, Excel, Power Point).
- Conoscenza della lingua inglese
- Si propone contratto da dipendente con CCNL Chimico farmaceutico
