At Kedrion, we believe that innovation and care must go hand in hand. Our mission is to enhance lives through our dedicated work in the field of rare and ultra-rare diseases.

As a global leader with a passionate team of 5,200 employees, we collect and fractionate plasma to produce and distribute 38 vital medicines worldwide, establishing ourselves as the fifth largest player in the plasma-derived products sector.

The RA Associate is responsible for the complete regulatory lifecycle management of assigned products in Rest of the World (RoW) markets. The role focuses on the maintenance and update of dossiers (registrations, renewals, and variations), ensuring full adherence to local regulatory requirements and effective communication between internal functions and international teams.

Main Responsability

• Maintains the Rest of the World Dossier (Reduced dossier) of the assigned products.
• Collaborates to the Rest of the World reportability assessment, in collaboration with the RoW RA, for the assigned products.
• Plans and executes the RA activities related to the assigned products in RoW countries, in collaboration with the RoW RA.
• Provides support to the relevant Kedrion functions for the activities in which the RA product expertise on RoW countries is concerned (i.e. project teams, GMP inspections, PSUR/RMP revision).
• Provides regularly updates on regulations, guidelines, etc. related to the area of competence.
• 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

• Bachelor's degree in a relevant scientific discipline 
• Experience in Regulatory Affairs within the Pharmaceutical or Biotech industry.
• Fluency in English 
• Attention to Detail
• Organizational Skills
• Communication
• Proactivity
• Problem-Solving

This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).