Experience

AF Consultora S.A.C.

• Peru
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Executive

  • Mar 2019 - Present

  - Coordinate regulatory activities for the mandatory notification of cosmetics, household cleaning products and personal hygiene products according to local standards and standards of the Andean Community of Nations- Coordinate regulatory activities for the sanitary authorization of pesticides

• Regulatory Affairs Assistant

  • Feb 2018 - Feb 2019



Permufes Factory International

• Regulatory Affairs Coordinator

  • Feb 2017 - Jan 2018

  - Coordinate regulatory submissions of cosmetic products in all countries where Perfumes Factory International has franchises (Colombia, Ecuador, Panama, Dominican Republic and Venezuela). - Review and approval of the cosmetic artworks according to local and international standards. - Regulatory assessment to investigate the feasibility of opening new franchises in Latin American countries. - Monitoring and control of projects with all the areas involved (marketing, supply chain, purchasing, legal). Show less



Merck S.A.

• Chile
• Executive Offices
• 1 - 100 Employee

• Regulatory Affairs Coordinator

  • Feb 2014 - Sep 2016

  Life cycle management of oncology, fertility, endocrinology and neurodegenerative diseases portfolio. MAA of biologicals products and chemical entities through Venezuelan electronic system (SIVERC). Legal, CMC and clinical variations. Safety variations. Creation of Product Information Leaflet. Management of regulatory tools (status and traceability, artworks, change controls, documentation management and promotional material). Interaction with global and regional functions, manufacturers and third-parties. Submissions and interactions with National Health Authorities. Show less



Daiichi Sankyo Venezuela, S.A.

• Regulatory Affairs Analyst

  • Jun 2012 - Feb 2014

  Preparation of dossiers for MAA of pharmaceutical specialties. Legal, CMC and clinical variations for chemicals and biologicals. Review and approval of artworks. Review and approval of promotional materials and advertising. Development of standard operating procedures of regulatory. Request information and documentation to headquarters and regional funtions. Preparation of dossiers for MAA of pharmaceutical specialties. Legal, CMC and clinical variations for chemicals and biologicals. Review and approval of artworks. Review and approval of promotional materials and advertising. Development of standard operating procedures of regulatory. Request information and documentation to headquarters and regional funtions.



Instituto Nacional de Higiene "Rafael Rangel" (Venezuelan National Health Authority)

• Assessor Pharmacist

  • Apr 2010 - Jun 2012

  Technical and scientific evaluation of MAA of viral, DNA recombinant and bacterial vaccines. Evaluations and approval of Legal and CMC variations of biological products. Batch release of vaccines. Quality control of bacterial, viral and DNA recombinant vaccines. Performing physical, chemical and biological assays. Teaching activities with interns. Technical and scientific evaluation of MAA of viral, DNA recombinant and bacterial vaccines. Evaluations and approval of Legal and CMC variations of biological products. Batch release of vaccines. Quality control of bacterial, viral and DNA recombinant vaccines. Performing physical, chemical and biological assays. Teaching activities with interns.



Universidad Central de Venezuela

• Venezuela
• Higher Education
• 700 & Above Employee

• Assistant Researcher

  • Oct 2009 - Mar 2012

  Molecular biology lab, school of pharmacy: apprentice of basic laboratory techniques of molecular biology (DNA extraction, PCR, electrophoresis, among others). Application of surveys, management of patient databases. Participation in multidisciplinary clinical research. Molecular biology lab, school of pharmacy: apprentice of basic laboratory techniques of molecular biology (DNA extraction, PCR, electrophoresis, among others). Application of surveys, management of patient databases. Participation in multidisciplinary clinical research.