Auxiliar Asuntos Regulatorios
Core
Support regulatory compliance by organizing technical documentation, tracking submissions with health authorities, and maintaining document control for pharmaceutical/medical device products.
Role type
Junior regulatory affairs assistant
Builds
Regulatory dossiers and technical documentation for health authority submissions
Domain
Healthcare / Pharmaceutical / Medical Devices
Required skills
Regulatory documentation management, Health authority correspondence, Document control, Basic technical translation, Office software proficiency
Preferred skills
Knowledge of NOM 059/240/241, ISO 13485 interpretation, COFEPRIS dossier preparation, Risk analysis, Intermediate written English
Responsibilities
Integrate and organize technical documentation for regulatory filings, Track regulatory submissions with health authorities, Prepare regulatory dossiers and protocols, Support legal filings and renewals, Coordinate information across internal departments, Maintain document control records
Seniority
Junior, entry-level