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Regulatory Affairs Specialist

2 mesi fa

Roma, Lazio, Italia Page Personnel A tempo pieno

**Job Summary**

Page Personnel is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.

**Key Responsibilities**

  • Manage and prepare regulatory dossiers (CTD) for submissions to US, EU, and other regulatory authorities.
  • Prepare and manage dossiers (Modules) following deficiency letters sent by authorities and applicable changes.
  • Manage and prepare renewals and annual reports.
  • Evaluate changes and support regulatory strategy for Investigational Medicinal Products (IMPD).
  • Support SOPs evaluation and editing.

**Requirements**

  • Degree in scientific subjects.
  • Regulatory experience in a pharmaceutical company.

**About Us**

Page Personnel is a leading recruitment agency that believes in diversity and inclusion. We promote equal opportunities and do not discriminate based on sex, race, age, religion, sexual orientation, or any other aspect that may be considered discriminatory.