Victoria César

Regulatory Affairs Coordinator at SteinCares
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Costa Rica, CR

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
You need to have a working account to view this content.

Experience

    • Costa Rica
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Coordinator
      • Nov 2021 - Present

    • Regulatory Affairs Senior Officer
      • Apr 2021 - Oct 2021

    • Costa Rica
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Regulatory Affairs Team Leader
      • 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.

    • Regulatory Affairs Pharmacist
      • 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.

    • Quality Control Analyst
      • 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.

  • NUTSA S.R.L
    • Argentina
    • Administrative Assistant
      • 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.

    • Development Analyst
      • May 2010 - Oct 2010

      Solutions and reagents preparation. New drugs development. Analytical method validation. Drug stability testing.

    • Regulatory Affairs Officer
      • 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.

    • Trainee
      • 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.

Education

  • 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

Community

You need to have a working account to view this content. Click here to join now