Adecco Italia SpA is looking for an administrative assistant for Regulatory Affairs Department of an important client. International reality in the pharmaceutical chemical Sector.
Major activities include (but are not limited to):
Administrative office routines:
•Is responsible for general administrative tasks, such as department administration.
•Performs periodic review of the annual budget of the department.
•Assists in department administrative tasks, such as managing purchase orders and invoices, handling suppliers; arranges staff meetings and other meetings; coordinates agendas, takes and circulates minutes; makes travel arrangements, manages expense reports, as applicable.
•Assists in compilation and submission of regulatory documents to the local regulatory authorities related to new applications, variations, renewals; prepares and files in autonomy: CPP and GMP certificate requests, SIS code requests/management, AUA requests/management, etc.
Regulatory Compliance:
•Either electronically or physically filing / archiving official documents of the department.
•Is responsible of all activities for handling the access to the Italian Agency front-end, also through the necessary submission of the relative power of attorneys (also for other concerned functions).
•Regular checking of certified email box (PEC); handles digital signature of the Country Leads and of her reports.
•Handling documents’ legalization, as required.
•Daily reviewing and dissemination of Official Gazette part I publications and Farmindustria communications.
•Handling the publication of notices on the Official Gazette part II (GURITEL platform).
•Reviews and circulates the monthly transparency list of generics.
•Assist the Market Research to quarterly update the global WPTD database.
•Keep the database of type I and I variations and other regulatory databases timely updated.
•Handles the notification of co-promotion agreement to the Agency and keeps the relative internal database updated.
•Participates in establishing and maintaining relevant Standard Operating Procedures to secure that the current regulations are complied with.
•Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Editing and labeling:
•Keeps the labelling databank FARMADATI/CODIFA updated; coordinates Electronic Medicines Compendium submi

Esperienze lavorative:
Segretario/a di direzione/Executive Assistant – 12 mesi

Titolo di studio:
Laurea Magistrale – Chimico / Biologico / Ambientale – Chimica e tecnologia farmaceutiche

Lingue conosciute:
Inglese: Parlato Ottimo – Scritto Ottimo – Comprensione Ottimo

Competenze:
Word Processor – Elaborazione testi – Word
Fogli di calcolo / elettronici – Excel, livello Ottimo
Browser per Internet – Microsoft Explorer
Posta elettronica/Messaggistica – Outlook, livello Ottimo
Sistemi Operativi – Windows XP, livello Ottimo
SAP – MM, livello Ottimo
Farmaco-Scientifico – Farmaceutica, livello Ottimo
Farmaco-Scientifico – Ricerca farmacoscientifica, livello Ottimo

Disponibilità oraria: Full Time

Osservazioni: Si offre contratto a tempo determinato con durata di 6 mesi e possibilità di inserimento diretto. Richiesto inglese fluente, conoscenza gestionale COMET ASSAY, SAP MODULO MM (ACQUISTI) e conoscenza delle attività di Regulatory Affairs per farmaci.

Candidati

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