REGULATORY AFFAIRS SPECIALIST, Lugano
Vor 4 Tagen
ER Services Sagl ricerca REGULATORY AFFAIRS SPECIALIST per azienda farmaceutica cliente di Lugano.
Responsabilità
- Gestire le procedure e gli adempimenti regolatori relativi alla registrazione ed alla commercializzazione di prodotti aziendali presso Autorità Regolatorie Internazionali.
- Esperienza minima di 2/3 anni maturata nel ruolo di Regulatory Affairs Specialist in ambito farmaceutico;
- Comprovata esperienza di interazione diretta con Autorità Regolatorie internazionali (Swissmedic; Health Canada; SFDA);
- Esperienza nella preparazione del modulo 1, inclusi gli stampati e i mock-ups;
- Buona conoscenza dei principali strumenti informatici e dei programmi di Regulatory Affairs (es. e-CTD Manager);
- Esperienza nella gestione di procedure di Lifecycle Management di una MA application, promotional review e compliance;
- Esperienza nella gestione di procedure regolatorie quali MAA, Variations, Scientific Advice, Orphan Designation, Paediatric Requirements;
- Eventuale esperienza nella gestione delle sezioni pre-cliniche e cliniche dei dossier registrativi (moduli 4 e 5);
Requisiti
- Laurea in materie scientifiche (es. CTF, Farmacia, Biotecnologie etc);
Data
16/05/2024
Posizione
4857 - REGULATORY AFFAIRS SPECIALIST
Location
Lugano (CH)
In caso d'interesse per la posizione proposta, allegare il Curriculum vitae in lingua Italiana e/o in lingua Inglese, possibilmente in file con formato Word o formato compatibile.
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