Regulatory Coordinator

hace 2 meses

Guayaquil FOMAT Medical Research
Requirements

Experience: 2 to 5 years in similar positions (Strong knowledge of regulatory processes in Ecuador – Essential).
Advanced English (essential) – Required, as the interview process will be conducted in English.

Technical knowledge of national and international regulations, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and experience with the ARCSA system.

Activities To Be Performed

Prepare documentation for the review of clinical studies by health authorities.
Carry out procedures before national and international regulatory entities.
Coordinate the translation of legal and technical documents.
Manage import/export permits and inventory control.
and follow up on studies submitted for approval.
Request and monitor regulatory documentation from the various Sites/Investigators/Coordinators of clinical studies.
Prepare reports for regulatory agencies.
Handle requirements from regulatory entities.
Plan and execute activities related to Registrations, Regulatory Affairs, and technical and commercial processes.
Maintain and organize regulatory document archives.
Ensure compliance with current national and international legal regulations.

Competencies

Leadership and influence
Organization
Collaboration
Goal orientation
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