Regulatory Affairs Junior/Specialist

Gefunden in: beBee jobs CH - vor 2 Wochen

Lugano, Tessin, Schweiz ADIENNE SA Vollzeit
Regulatory Affairs Junior/SpecialistPosted on 10 April April 2024 by Alessandra Berardi

Scopo della posizione

Gestire le procedure e gli adempimenti regolatori relativi alla registrazione ed alla commercializzazione di prodotti aziendali presso Autorità Regolatorie Internazionali.

Requisiti necessari e indispensabili per ricoprire il ruolo:

  • Esperienza minima di 2/3 anni maturata nel ruolo di Regulatory Affairs Junior o Specialist in ambito farmaceutico;
  • Comprovata esperienza di interazione diretta con Autorità Regolatorie internazionali (e.g. FDA; 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);

Competenze tecniche:

  • Esperienza nella gestione di procedure di Lifecycle Management di una MA application (e.g. renewal, 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).

Completano il profilo:

  • Laurea in materie scientifiche (es. CTF, Farmacia, Biotecnologie etc.)
  • Ottima e professionale conoscenza della lingua inglese scritta e parlata.
Job Category: Regulatory AffairsJob Type: Full TimeJob Location: SwitzerlandWorking Class: EmployeeSeniority: 3 years
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