Regulatory affairs Senior
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Asuntos Regulatorios Insumos para la Salud.
Preparing country-specific submission ready dossiers, manage Agency questions when required and ensure post-approval activities to take place for those submissions. (drugs, foods etc)
The work is very varied and depends on the client’s needs. Sometimes I work for a set period of time as part of their in-house regulatory team. Other times I will work in my office preparing licence applications for clients, or product licence variations.
Medicines, medical devices, foods, cosmetics and others.