Regulatory affairs specialist II
1 settimana fa
Mansione
Randstad Inhouse Services, divisione specializzata di Randstad Italia Spa, Specialty Pharma ricerca per importante azienda multinazionale del settore chimico farmaceutico:
Regulatory affairs specialist II
La risorsa sarà inserita nel team con un contratto di somministrazione pari a 6 mesi.
Responsabilità
La risorsa si occuperà di:
scrivere ed esaminare dossier normativi per garantire gli standard correnti,
verificare la compliance del sito produttivo, secondo norme locali ed internazionali.
supportare il cliente in caso di confronto con gli enti normativi,
esaminare i file normativi per prodotti commerciali (MAA, NDA, BLA, ANDA) e prodotti clinici (IMPD, IND).
Competenze
Le competenze richieste sono:
esperienza nel regulatory affairs role,
ottima conoscenza della lingua inglese,
ottima comprensione delle linee guida Emea, USA, Giappone e Cina,
predisposizione al team working e ottime capacità di problem solving.
La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l' informativa sulla privacy Randstad ( ) ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
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