Regulatory affairs specialist II

2 settimane fa


Ferentino FR, Italia Randstad Italia spa A tempo pieno

Settore: manifatturiero & produzione
Categoria: Tecnici specializzati, qualità
Orario di lavoro: Full Time
Contratto: Somministrazione
Numero posti: 1
Luogo di lavoro: Ferentino

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.

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).
Requisiti: 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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