regulatory affairs specialist

vor 2 Wochen

Lugano, Tessin, Schweiz ERServices Vollzeit

Regulatory Affairs Specialist



Posizione

Regulatory Affairs Specialist

Location

Lugano (CH)

Dettaglio

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.

Requisiti

  • Laurea in materie scientifiche (es. CTF, Farmacia, Biotecnologie etc);
  • 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);
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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