Temporary Regulatory Affairs Associate, Plasma Master File - Castelvecchio Pascoli, Italia - Adhr

Descrizione

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/