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.
- 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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