Regulatory Affairs Expert

hace 2 meses


Xico, México Fenixfarma Mexico City, Mexico A tiempo completo

Regulatory Affairs Specialist Job Description

Key Responsibilities:

  • Prepare dossiers for drug products, ensuring compliance with COFEPRIS regulations.
  • Coordinate with manufacturers and regulatory authorities to ensure product compliance.
  • Develop risk management plans for new molecules and submit reports to regulatory authorities.
  • Provide market research and forecasts for drug products based on IMSS tender reports.

Requirements:

  • Chemist/ Biologist and Pharmacist Diploma.
  • 1 year experience in drug products dossier preparation for submission.
  • Knowledge of online submission of dossier on DIGIPRIS.
  • High communication skills in English & Spanish.

About the Role:

This is a full-time on-site position in Polanco CDMX, Mexico, with a monthly income of over a thousand US dollars.



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