Regulatory Affairs Officer
Current- Preparation of dossier for new marketing application submission in LATAM and Caribbean countries (technical and legal documentation, artworks, labels, etc...)- Review and compilation of documentation for submission of variations, renewals and deficiency letters.- Preparation of regulatory intelligence reports- Follow-up on submissions and approvals, as well as recording relevant information in databases and electronic systems- Review and update labels and artworks to comply with local regulations- Project coordination for the submission of safety variations.Achievements: Preparation of a workload report to optimize resources and support project planning