Temporary Regulatory Affairs Associate, Plasma Master File
Adhr
Castelvecchio Pascoli
30
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Azienda: Adhr Castelvecchio Pascoli
Previsione stipendio medio: circa 30.000-35.000 euro annui
Orari: full time
Esperienza: Esperienza in Affari Regolatori preferita
Titolo di studio: Laurea in Scienze della Vita o campo correlato
LA SPECIALIZZAZIONE HELATHCARE &PHARMA DI ADHR GROUP, RICERCA PER AZIENDA FARMACEUTICA ITALIANA: The candidate will report to RA Manager and will carrie out the following activities: • Provides support for Plasma master file and related activities globally. • Collaborates in the reportability assessment for PMF. • Prepares PMF regulatory applications in compliance with business targets and relevant second step procedures for the concerned finished products. • Prepares Import Dossiers. • May participate during the inspections of the Authorities providing regulatory support on topics related to PMF. • Provides regularly updates on regulations / guidelines, etc. related to the area of competence. • Provides support to RA and Kedrion functions for plasma-related topics. • With regard to PMF regulatory applications, second step procedures and import dossier: o Contributes to define the application requirements on the basis of the EU legislation; o prepares the technical and administrative sections and requests documentation from the competent departments; o Analyses and transfers the list of questions and the commitments received from the Authorities to the competent Functions and prepares the related answers; o Assembles the whole documentation and take care of the submission within the defined timelines; o Informs the relevant company departments on the procedure status; o Archives the documents related to the regulatory application, update the planning and tracking tools. Requirements: • Bachelor’s degree in Life Sciences or related field • Experience in Regulatory Affairs is preferred • Good knowledge in written and oral English • Communicative attitudes Location: Castelvecchio Pascoli + Smart Working Orario di lavoro: full time Contratto: da valutare in base alle Seniority del candidato Le ricerche sono rivolte a candidati dell’uno e dell’altro sesso ai sensi delle L. 903/77 e L. 125/91.
I candidati sono invitati a leggere l’informativa privacy sul sito di Adhr Group ai sensi dell’art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).
ADHR GROUP – Agenzia per il lavoro S. p. a.
Iscr.
Albo Agenzie per il Lavoro Sez.
I – Aut.
Min. prot. n. 13/I/....
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