- 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.
- 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.
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Junior Regulatory Affairs Specialist - Lazio, Italia - Adecco Italia Spa
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)
Esperienze lavorative:
Regulatory affairs specialist - 12 mesi
Titolo di studio:
Laurea Magistrale
Lingue conosciute:
Inglese:
Comprensione Buono
Competenze:
Word Processor - Elaborazione testi - Word, livello Ottimo
Fogli di calcolo / elettronici - Excel, livello Ottimo
Farmaco-Scientifico - Farmaceutica, livello Ottimo
Disponibilità oraria:
Full Time