RA Associate, PMF - Castelvecchio Pascoli, Italia - Kedrion Biopharma
Descrizione
Kedrion Biopharma is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.
Temporary Regulatory Affairs Associate, Plasma Master File
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