Regulatory Affairs Consultant

6 mesi fa


Roma, Italia Pharma D&S A tempo pieno

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:

- 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

Retribuzione: €30.000,00 - €32.000,00 all'anno

Benefit:

- Buoni pasto
- Orario flessibile

Orario:

- Dal lunedì al venerdì

Tipi di retribuzione supplementare:

- Quattordicesima
- Tredicesima



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