REGULATORY AFFAIRS SPECIALIST

Vor 4 Tagen


Lugano, Schweiz ERServices Vollzeit

4857 - REGULATORY AFFAIRS SPECIALIST

Data

16/05/2024

Posizione

4857 - REGULATORY AFFAIRS SPECIALIST

Location

Lugano (CH)

Dettaglio

ER Services Sagl ricerca REGULATORY AFFAIRSSPECIALIST per azienda farmaceutica cliente di Lugano.

Responsabilità

·Gestire le procedure e gli adempimentiregolatori relativi alla registrazione ed alla commercializzazione di prodottiaziendali presso Autorità Regolatorie Internazionali.

Requisiti

·Laureain materie scientifiche (es. CTF, Farmacia, Biotecnologie etc);

·Esperienzaminima di 2/3 anni maturata nel ruolo di Regulatory Affairs Specialist inambito farmaceutico;

·Comprovataesperienza di interazione diretta con Autorità Regolatorie internazionali Swissmedic; Health Canada; SFDA);

·Esperienzanella preparazione del modulo 1, inclusi gli stampati e i mock-ups;

·Buonaconoscenza dei principali strumenti informatici e dei programmi di RegulatoryAffairs (es. e-CTD Manager);

·Esperienzanella gestione di procedure di Lifecycle Management di una MA application promotional review e compliance);

·Esperienzanella gestione di procedure regolatorie quali MAA, Variations, Scientific Advice,Orphan Designation, Paediatric Requirements;

·Eventualeesperienza nella gestione delle sezioni pre-cliniche e cliniche dei dossierregistrativi (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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