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Regulatory Affairs Expert

2 settimane fa

Milano, Lombardia, Italia Agc Biologics A tempo pieno

About Us

Agc Biologics, a leader in the Cell & Gene Therapy field, is seeking an experienced Regulatory Affairs expert.

Main Responsibilities:

  • Support customers with regulatory dossier filing, including CMC document revisions and responses to Competent Authority requirements;
  • Coordinate information collection from technical teams for sharing with customers;
  • Assist customers with regulatory impact assessments of change controls related to product processes and testing;
  • Maintain GMP Manufacturing Authorization for 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;
  • Stay updated on current legislation, guidelines, and regulations;
  • Participate in Regulatory associations and committees;
  • Collaborate in integrating the Corporate Quality System.

Requirements

  • Scientific Master Degree;
  • At least 10 years of experience in RA topics, with a focus on ATMP being a plus;
  • Proficient English skills.