Regulatory Affairs Senior Officer

3 settimane fa

Aprilia, Italia Randstad Italia Spa A tempo pieno

Mansione Randstad Talent Selection, divisione di Randstad Italia specializzata nella Ricerca &amp, Selezione di candidati qualificati, ricerca per azienda chimico farmaceutica un REGULATORY AFFAIRS SENIOR OFFICER Si offre: inserimento a scopo assunzione a tempo indeterminato, Luogo di lavoro: Aprilia (LT) Responsabilit Compiti e responsabilit : - Predispone la documentazione necessaria alla sottomissione delle richieste di AIC e delle variazioni richieste (internamente o esternamente) alle diverse Autorit - Predispone la documentazione necessaria per la sottomissione di modifiche essenziali e non essenziali per il mantenimento dell’autorizzazione alla produzione - Esegue l’aggiornamento della documentazione meno recente in accordo ai nuovi canoni richiesti dalla legislazione - Cura i contatti con determinati clienti al fine di risolvere problematiche contingenti, - Nell'ambito delle proprie mansioni svolgere attivit anche per le Societ del Gruppo a cui l’Azienda presta servizi afferenti all’area della Direzione Medica - Collabora con la Regulatory Affairs Specialist e con gli altri dipartimenti aziendali per le attivit di competenza - Supporta la Regulatory Affairs Manager per le attivit di competenza - Verificare, con il Dipartimento Farmacovigilanza, le pratiche e/o la documentazione per l’ottenimento delle autorizzazioni di nuove specialit farmaceutiche - Collabora con il Dipartimento Farmacovigilanza relativamente alle informazioni di sicurezza del prodotto Competenze Si richiede: - Laurea in ambito chimico farmaceutico - esperienza di almeno 3 anni in aziende titolari AIC - esperienza nella scrittura di dossier di registrazione con particolare riferimento al mod 3 - lingua inglese - uso programmi e-CTD La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy Randstad (https://www.randstad.it/privacy/) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR). vetrinabakeca

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