Junior Regulatory Affairs Specialist

4 settimane fa

Rome, Italia Adecco Italia SPA A tempo pieno
Adecco italia Spa is looking for an important client in the pharmaceutical sector a

JUNIOR REGULATORY AFFAIRS SPECIALIST

Basic Functions & Responsibility (may not be limited to)
•Be responsible for the management of the authorized products through timely submission of variations, application renewals and supplemental marketing authorizations.
•Carry out linguistic checks, high quality review of translations and QRD checks on Summary of Product Characteristics and Patient Information Leaflets.
•Timely preparation and maintenance of local Summary of Product Characteristics, Patient Information Leaflets, packaging material and other applicable Regulatory documents.
•Perform review of artworks and relevant artwork management.
•Keep Regulatory files and archives updated and complete and stay informed about relevant EU and local regulations and guidelines.
•Secure timely and adequate information sharing of Regulatory items related to deletions and or product suspensions.
•Ensure compliance with the Company procedures and timely completion of the Company professional trainings.

Job Requirements
•Master degree in pharmacy or other life science or equivalent.
•Minimum 1 year in a regulatory position with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
•Knowledge of Italian and European Regulatory procedures (NAT, CAP, MRP/DCP).
•Be capable of using of using the different Company database and systems which are instrumental for a compliant management of the daily Regulatory activities.
•Good verbal and written communication skills are essential, as are good organizational and planning abilities.
•Attention to detail and flexibility in managing different deadlines at the same time.
•Capable of working both alone and as part of a team.
•The candidate must be proficient in Italian and English, as well as be capable of PC use with regard to word-processing, spreadsheets and database applications.
•A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.

We offer a fixed-term contract for maternity replacement. Level C2 - Annual salary 32k. Start date 15 april 2024.

Data inizio prevista: 15/04/2024

Categoria Professionale: Scientifico / Farmaceutico

Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA

Città: Roma (Roma)

Esperienza lavorativa:
  • Regulatory affairs specialist - 12 mesi


Istruzione:
  • Laurea Magistrale

Conoscenze linguistiche:
  • Inglese - Livello Buono

Competenze richieste:
  • Word Processor - Elaborazione testi - Word, livello Ottimo
  • Fogli di calcolo / elettronici - Excel, livello Ottimo
  • Farmaco-Scientifico - Farmaceutica, livello Ottimo

Disponibilità oraria:
  • Full Time


I candidati, nel rispetto del D.lgs. 198/2006, D.lgs 215/2003 e D.lgs 216/2003, sono invitati a leggere l'informativa sulla privacy consultabile sotto il form di richiesta dati della pagina di candidatura (Regolamento UE n. 2016/679).

ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa sulla pagina dedicata al phishing su adecco.it.
Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).

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