Regulatory Affairs Consultant
5 mesi fa
Regulatory Affairs Consultant
Pharma D&S ricerca, per la sede di Roma, un/una Regulatory Affairs Consultant con almeno 2/3 anni di esperienza nel ruolo:
La risorsa selezionata si occuperà di:
- Collaborare alla definizione della strategia regolatoria
- Preparare la documentazione di Qualità (Modulo 3 e 2.3)
- Preparare la domanda di deposito di un Master File della Sostanza Attiva (ASMF)
- Preparare variazioni e rinnovi AIC
- Archiviare la documentazione prodotta durante le varie attività
- Fornire supporto durante le ispezioni interne e presso il cliente
- Preparare SOP specifiche del settore
- Interagire con le principali Autorità Regolatorie
I requisiti:
- Laurea in discipline scientifiche
- Preferibile conseguimento di un Master in attività regolatorie
- Buona conoscenza della lingua inglese
- Esperienza pregressa in ambito farmaceutico
- Ottime competenze relazionali
- Ottime capacità organizzative e rispetto delle scadenze definite
About Pharma D&S
Pharma D&S è una società di consulenza nel settore Farmaceutico e Life Science in grado di fornire servizi tempestivi, efficienti e di elevata qualità nell’ambito di: Quality & Process, Regulatory Affairs, Farmacovigilanza e Studi Clinici.
Contratto di lavoro: Tempo pieno, Tempo indeterminato
Stipendio: €30.000,00 - €32.000,00 all'anno
Benefit:
- Buoni pasto
Orario:
- Dal lunedì al venerdì
- Orario flessibile
Tipi di retribuzione supplementare:
- Quattordicesima
- Tredicesima
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