Experience

IVAX Argentina - Teva Group Member

• Regulatory Affairs Manager

  • Oct 2015 - Present

  Regulatory Affairs Senior Manager, leading the preparation of regulatory dossiers from local manufactured products to be registered in all the region. (Markets involved: Mexico, Chile, Peru, Venezuela & Brazil).Main Responsibilities:- Dossier Preparation for submission in the target countries.- Maintenance and post-registry variation of involved products in target markets- Regulatory and Strategy support for regional projects in the country



Roche

• Regulatory Affairs chief - Diagnostics Division

  • Apr 2014 - Oct 2015

  Regulatory Affairs IVD and medical devices management in Argentina. The position involves the management and prioritization of the new products' registration plan, instruments' re-validation and maintenance of the already registered products.Main Responsibilities:- Leadership of the IVD and instruments registration process.- Post-approval variations and maintenance of products.- Give advice as regards the regulatory environment for new products and projects.- Give support to… Regulatory Affairs IVD and medical devices management in Argentina. The position involves the management and prioritization of the new products' registration plan, instruments' re-validation and maintenance of the already registered products.Main Responsibilities:- Leadership of the IVD and instruments registration process.- Post-approval variations and maintenance of products.- Give advice as regards the regulatory environment for new products and projects.- Give support to the Technical Responsible person by acting as Co-Technical Responsible person. Show more Show less



Ivax Pharmaceuticals

• Regulatory Affairs Coordinator

  • Dec 2012 - Mar 2014

  Regulatory Affairs OTC products management of products in Argentina resulting from the global joint venture of Procter & Gamble and TEVA.Main Responsabilities:- Leader in the registry of Drug Products, Herbal Medicines, Food and/or Food Suplements in Argentina. - Follow up of dossiers (registry dossiers, maintenance/variation dossiers, GMP inspection dossiers) in Argentina.- Maintenance and post-registry variations applications of involved products.- Regulatory and Strategy… Regulatory Affairs OTC products management of products in Argentina resulting from the global joint venture of Procter & Gamble and TEVA.Main Responsabilities:- Leader in the registry of Drug Products, Herbal Medicines, Food and/or Food Suplements in Argentina. - Follow up of dossiers (registry dossiers, maintenance/variation dossiers, GMP inspection dossiers) in Argentina.- Maintenance and post-registry variations applications of involved products.- Regulatory and Strategy support for new projects in the country.- Direct contact with Health Authorities.- Review and approval of product´s artworks. - Review and approval of Promotional Materials. Show more Show less



Quintiles

• Regulatory Officer II

  • Feb 2010 - Dec 2012

  Main Responsabilities as Regulatory Officer at Quintiles: - Assembling, reviewing and translation review of Marketing Authorization Application (MAA) Dossiers in Latin America (LatAm).- Submission of dossiers to the Health Authority (HA) in Latin America (LatAm).- Follow up of dossiers submitted to the Health Authorities.- Contingency management when applicable.- Regulatory support in LatAm Marketing Application Authorizations- Regulatory Consulting



GlaxoSmithKline

• Quality Assurance Coordinator

  • Nov 2008 - Jan 2010

• Regulatory Affairs Analyst

  • Nov 2005 - Oct 2008