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.
RA Specialist, International Product Owner The person selected will report to the RA Manager and will have the following responsibilities: • Maintains the Rest of the World Dossier (Reduced dossier) of the assigned products and performs the Rest of the World reportability assessment, in collaboration with the RoW RA.• Plans and executes the RA activities related to the assigned products in RoW countries, in collaboration with the RoW RA.• Support GPOs with product RA activities and provides procedural support to the whole group.• Provides support to the relevant Kedrion functions for the activities in which the RA product expertise on RoW countries is concerned ( project teams, GMP inspections, PSUR/RMP revision).
• With reference to registrations, renewals and variations:• Prepares the technical sections of RoW dossier and requests documentation from the competent departments, in compliance with the local requirements provided by the Row RA;• Analyses and sends the list of questions and the commitments received from the International Team to the competent Functions, and prepares the related answers;• Creates and maintains up to date the baseline dossiers of the products of responsibility in ROW countries.
Requirements • Scientific Degree• 2 years of experience in Pharma Industries on regulatory procedures management, or experience in Quality Operations or Manufacturing fields.• English fluent• Ability to work in cross- functional teams• Problem solving and analytical mindset