Regulatory Affairs Specialist

1 giorno fa


Milano, Lombardia, Italia Page Personnel A tempo pieno
Regulatory Affairs Specialist

Page Personnel is seeking a highly skilled Regulatory Affairs Specialist to join our client, a leading Pharmaceutical Company in Milan. As a key member of the team, you will be responsible for managing and preparing regulatory dossiers for submissions to the US, EU, and extra-EU markets.

Main Responsibilities:
  • Managing and preparation of regulatory dossier (CTD) for submissions of human drug substances (Applicant and Restricted part)
  • Preparation and management of dossiers (Modules following deficiency letters sent by authorities and following the applicable changes)
  • Managing and preparations of Renewals and annual report
  • Evaluation of changes
  • Support, tracking and management of customer's variations
  • Support to regulatory strategy for Investigational Medicinal Products (IMPD)
  • Support to SOP's evaluation and editing
Requirements:
  • Degree in scientific subjects
  • Regulatory experience in a pharmaceutical company

This is an exciting opportunity for a career-driven individual to join a dynamic team and contribute to the success of our client.



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