IndirizzoAdecco 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).
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Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).
