Experience

medix®

• Mexico
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Regulatory Affairs

  • Jun 2022 - Present

  México



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Reasercher

  • Jul 2022 - Present



Laboratorios Sanfer

• Mexico
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Analytical/Quality Control Chemist and Chemist-QC-Stability

  • Nov 2020 - Apr 2022

  Santiago Tianguistengo de Galeana, México, México Experience in techniques for physicochemical, biological and microbiological analysis, GDP documentation in a cGMP laboratory. Development of databases for laboratory management, inventories, macros with quality applications. Preparation of technical sheets, standardized procedures, analysis protocols of regulatory compliance. Coordination with different departments of the pharmaceutical industry, mainly quality assurance, regulatory affairs, validation and production.



Levic

• Mexico
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Regulatory Affairs Analyst

  • Dec 2019 - Nov 2020

  Área metropolitana de Ciudad de México Validation of regulatory compliance of health supplies and products for distribution with the approval of the Ministry of Health. Review of legal documentation for purposes of sanitary registration, advertising, importation of health products, procedures in regulatory entities. (COFEPRIS) Regulatory compliance inspections for medical device and drug distribution centers, staff training and external audits of the quality management system.



Empacadora Therbal, S.A. de C.V.

• Head Of Regulatory Affairs

  • Aug 2018 - Sep 2019

  México Preparation, management and monitoring of procedures before regulatory entities (COFEPRIS). Research and development of new products; from the stage of Research, Formulation, production and regulatory compliance, physicochemical, microbiological analysis, use of national and international pharmacopoeias. Communicate on time and accurate Mexico specific regulatory requirements and advise business partners of regulatory strategy and requirements. Conformation of CTD files to obtain sanitary… Show more Preparation, management and monitoring of procedures before regulatory entities (COFEPRIS). Research and development of new products; from the stage of Research, Formulation, production and regulatory compliance, physicochemical, microbiological analysis, use of national and international pharmacopoeias. Communicate on time and accurate Mexico specific regulatory requirements and advise business partners of regulatory strategy and requirements. Conformation of CTD files to obtain sanitary registrations for the commercialization of the new developed products. Show less



Hospital Juárez De México

• Analista de Biología Molecular

  • Dec 2017 - Jun 2018

  Ciudad de México y alrededores, México