Regulatory Affairs

Main responsibilities: Managing and preparation of regulatory dossier (CTD) for submissions of human drug substances (Applicant and Restricted part) for US, EU and extra-EU submissions.
Preparation and management of dossiers (Modules 1-2-3) 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.
The resource must have: - degree in scientific subjects - Regulatory experience in a pharmaceutical company Important career opportunity For our client