Regulatory Affairs Manager - Milano, Italia - AGC Biologics

AGC Biologics
AGC Biologics
Azienda verificata
Milano, Italia

3 settimane fa

Piero Bianchi

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee
Descrizione

Agc Biologics, leader company in Cell & Gene Therapy field, is looking for a Regulatory Affairs Manager

Main Responsabilities:


  • Support the customers in regulatory dossier filing, including the revision of the CMC documents for regulatory submissions and the answer to Competent Authority requirements;
  • Coordinate and collect information from technical teams to be shared with the customer;
  • Support the customers in performing regulatory impact assessments of change controls related to the process and testing of products;
  • Maintain the GMP Manufacturing Authorization of the Facility;
  • Evaluate change controls related to the Facility in cooperation with QP;
  • Manage direct contact with Competent Regulatory Authorities;
  • Support the organization of regulatory inspections;
  • Keep updated on current legislation, guidelines and other regulations;
  • Take part to Regulatory associations and committee;
  • Collaborate for the integration of the Corporate Quality System

Requirements:


  • Scientific Master Degree;
  • At least 10 years experience in RA topics, focus in ATMP will be a plus;
  • Proficient English.
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