Junior Regulatory Affairs Specialist - Roma, Italia - Adecco Italia
Descrizione
Adecco italia Spa is looking for an important client in the pharmaceutical sector aJUNIOR REGULATORY AFFAIRS SPECIALIST
Basic Functions & Responsibility (may not be limited to)
- 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.
- Master degree in pharmacy or other life science or equivalent.
- 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.
- A sound appreciation of the interactions and relationships of the dept with other groups internally is expected.
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
ATTENZIONE:
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