Regulatory Specialist Intern

3 settimane fa


Roma, Italia IMCD Deutschland GmbH & Co KG A tempo pieno

Attività:
Raccolta e archiviazione documentazione regolatoria per il settore farmaceutico, nutraceutico, cosmetico, sintesi e agrochimico.
Supportare i clienti per rispondere a richieste regolatorie standard e successivo invio di documentazione (dossier e statement regolatori).
Interfacciarsi attivamente con i fornitori e con le consociate allo scopo di creare un set documentale e un background tecnico-regolatorio che rappresenti nel rapporto con i clienti un valore aggiunto per lo sviluppo del business.
Verificare e compilare dossier, questionari e documentazione tecnico-regolatoria dei prodotti/settori affidati.
Preparare e notificare le variazioni ai clienti supportando il processo di Change Management.
Partecipare a training interni riguardanti nuove materie prime/nuovi fornitori/aggiornamenti regolatori.
Partecipare alle iniziative promosse dalle associazioni di categoria italiane ed europee per i settori affidati.
Collaborare/partecipare alle attività/progetti di HSEQR&S locale e di Gruppo.
Uso corretto ed efficace del CRM e del ERP aziendale per lo svolgimento delle mansioni sopra esposte.
Competenze richieste:
Imparare a verificare ed archiviare la documentazione regolatoria.
Saper supportare la clientela attraverso l’invio di documenti tecnico-regolatori adeguati alle aspettative.
Conoscere aspetti regolatori di base legati al mercato farmaceutico, nutraceutico, cosmetico, sintesi e agrochimico.
Imparare a collaborare e comunicare con gli interlocutori interni: team HSEQ, referenti commerciali di ogni settore.
Imparare a collaborare e comunicare con gli interlocutori esterni: fornitori e clienti.
Sviluppare conoscenza dei principali sistemi gestionali aziendali (SF, JDE).

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