Victoria César
Regulatory Affairs Coordinator at SteinCares- Claim this Profile
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Bio
Experience
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SteinCares
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Costa Rica
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Regulatory Affairs Coordinator
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Nov 2021 - Present
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Regulatory Affairs Senior Officer
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Apr 2021 - Oct 2021
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Gutis
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Costa Rica
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Regulatory Affairs Team Leader
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Sep 2018 - Mar 2021
Responsible for the Regulatory Affairs area of all the countries in which the Company has operations. Work planning and organization. Personnel in charge. Visits to the different Ministries of Health.
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Regulatory Affairs Pharmacist
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Sep 2017 - Sep 2018
Submissions, renewals and post-registration changes of health product licences in Costa Rica, Central and South American countries. Provide response to Regulatory Authorities. SOPs writing and updating. Change control and deviations management.
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LABORATORIO AKKRUM S.A.
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Argentina
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Quality Control Analyst
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Aug 2011 - Jun 2012
Solutions and reagents preparation. Purified water, packaging, raw materials, bulk and finished drugs analysis. Solutions and reagents preparation. Purified water, packaging, raw materials, bulk and finished drugs analysis.
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NUTSA S.R.L
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Argentina
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Administrative Assistant
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Dec 2010 - Jul 2011
Management of suppliers orders. Material and product delivery organization. Organization of education programs and products presentation for institutions and clients. Search for potential clients and suppliers. Management of suppliers orders. Material and product delivery organization. Organization of education programs and products presentation for institutions and clients. Search for potential clients and suppliers.
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Development Analyst
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May 2010 - Oct 2010
Solutions and reagents preparation. New drugs development. Analytical method validation. Drug stability testing.
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Regulatory Affairs Officer
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Apr 2008 - Apr 2010
Submissions, renewals and post-registration changes of health product licences. SOPs writing and revision. Give response to product complaints and queries. Returns controls.
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BIOQUÍMICA INTEGRAL
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Argentina
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Trainee
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Jan 2007 - Jul 2007
Solutions and material preparation. Development of various tasks corresponding to the laboratory technician in diverse areas: Chemistry, Hematology and Serology. Solutions and material preparation. Development of various tasks corresponding to the laboratory technician in diverse areas: Chemistry, Hematology and Serology.
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Education
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Universidad Latina de Costa Rica
Bachelor's degree, Pharmacy -
Colegio Santo Domingo
High School Diploma, Economy and Organization Management -
Alianza Francesa de Costa Rica
French -
Universidad Nacional de La Matanza
Portuguese -
PQE
On-site courses -
Microbiología Farmacéutica
Medicines Technical Prequalification Course -
Universidad de Ciencias Médicas
Virtual Training in Regulatory Affairs -
Universidad de Costa Rica
Basic Pharmacovigilance Course for Health Professionals -
Colegio de Farmacéuticos de Costa Rica
On-site course, Sanitary Registry of Natural Medicinal Products -
Colegio de Farmacéuticos de Costa Rica
On-site Course, Sanitary Registry of Dietary Supplements -
Capacitarte
Virtual course, Emotional intelligence in the company