Experience

Aspen Labs

• United States
• Advertising Services
• 1 - 100 Employee

• LATAM REGULATORY AFFAIRS COORDINATOR

  • Dec 2020 - Present



Apotex

• Belgium
• Wholesale
• 1 - 100 Employee

• Regulatory Affairs Associate

  • Jun 2017 - Dec 2020

  Dossier preparation in Mexico for drug producst and medical devices (NMA, renewals, variations)Preparation of international dossiers, NMA, renewals and variations in Latin American Countries (Panama, Costa Rica, Trinidad and Tobago, Dominican Republic, Nicaragua, Cuba, Guatemala, Honduras, El Salvador, Chile, Argentina, Paraguay, Colombia, Perú, Uruguay, etc).Request of GMP´s, Free sale Certificates and CPP´s Dossier preparation in Mexico for drug producst and medical devices (NMA, renewals, variations)Preparation of international dossiers, NMA, renewals and variations in Latin American Countries (Panama, Costa Rica, Trinidad and Tobago, Dominican Republic, Nicaragua, Cuba, Guatemala, Honduras, El Salvador, Chile, Argentina, Paraguay, Colombia, Perú, Uruguay, etc).Request of GMP´s, Free sale Certificates and CPP´s



Neolpharma

• Mexico
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Coordinator of Validation

  • Aug 2016 - Jun 2017

  Development of programs to validate analytical methods based on regulatory requirements.Evaluation of resources for development and maintenance of validations and analytical transfers.Issuance of SOPs.Document information generated during analytical validations and transfers. Development of programs to validate analytical methods based on regulatory requirements.Evaluation of resources for development and maintenance of validations and analytical transfers.Issuance of SOPs.Document information generated during analytical validations and transfers.



Psicofarma

• Mexico
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Regulatory Affairs Associate

  • Jan 2015 - Aug 2016

  Dossier preparation in Mexico for drug products (NMAs, renewals, variations)Dossier preparation for Latin America countries Dossier preparation in Mexico for drug products (NMAs, renewals, variations)Dossier preparation for Latin America countries



Neolpharma SA de CV

• Mexico
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Prácticas

  • Jul 2013 - Dec 2014