Ana Luisa Avila

Regulatory Associate at Redica Systems
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Contact Information
us****@****om
(386) 825-5501
Location
Fortaleza, Ceará, Brazil, BR
Languages
  • Portuguese Native or bilingual proficiency
  • English Full professional proficiency
  • Spanish Limited working proficiency

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Experience

    • United States
    • Information Services
    • 1 - 100 Employee
    • Regulatory Associate
      • May 2022 - Present

    • United States
    • Software Development
    • 1 - 100 Employee
    • Regulatory Associate
      • Jan 2021 - May 2022

      Regulatory Affairs Associate responsible for supporting and coordinating Regulatory Intelligence, proactive global monitoring and surveillance activities of the Medical Device and Pharma, especially for LATAM. Informing manufacturers, importers, and distributors of medical devices about new regulations, and supporting requests related to regulatory intelligence queries or information acting in the analysis of the regulatory situation. Assisting in the development of new modules and software, providing updated and recently released data provided from the MOH. Show less

    • Netherlands
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Technical Sales Services
      • Jan 2019 - Dec 2020

      • Experience in receiving and managing customer support inquiries with knowledge in API products, pharmaceutical regulations (EMA and ANVISA), and quality issues (e.g., complaints, recalls). • Responsible for reviewing ISOPs for Regulatory Affairs and Marketing and Sales departments, according to EDQM (Quality Management System), improving the reliability of the documents and reducing the customers' complaints. • Database monitoring to track all company requests for regulatory documentation (e.g., CEPs, COAs, Manufacturing License, DMFs), reducing customer response time from 5 business days to 2 business days. • Coordination of complaints process and deviations procedures - Trackwise system. • Organization and follow-up of GMP audits (internal approvals, NDA with Legal department support, customer guidance, and CAPA procedure in connection with CMOs). • Expansion of business opportunities for Centrient Pharmaceuticals in the API markets through technical support and innovation, working closely with commercial counterparts in understanding and defining market and customer needs. Show less

    • Brazil
    • Retail
    • 700 & Above Employee
    • Technical Sales Support Specialist
      • Dec 2015 - Dec 2016

      • Accomplished strong sales support to Brazilian customers, providing support on questions related medical information and medicines ( E.g. adverse drug reactions, storage conditions and pharmacokinetic). • Lead customer satisfaction with an excellent pre-sales and post-sales. • Coordination of complaints. • Sales target 100% achieved in a specific pre-designated region • Accomplished strong sales support to Brazilian customers, providing support on questions related medical information and medicines ( E.g. adverse drug reactions, storage conditions and pharmacokinetic). • Lead customer satisfaction with an excellent pre-sales and post-sales. • Coordination of complaints. • Sales target 100% achieved in a specific pre-designated region

    • Brazil
    • Higher Education
    • 700 & Above Employee
    • Pharmaceutical information support - Medication Information Center (CIM)
      • Aug 2013 - Aug 2015

      • Drove technical information to Brazilian population with less resources, answering pharmaceutical questions, as drug reactions, storage conditions and pharmacokinetic of multiples pharmaceutical products. • Drove technical information to Brazilian population with less resources, answering pharmaceutical questions, as drug reactions, storage conditions and pharmacokinetic of multiples pharmaceutical products.

Education

  • Instituto Racine
    Postgraduate Degree, Regulatory Affairs Specialist
    2021 - 2022
  • Faculdade Unyleya
    Master of Business Administration - MBA, Logistics, Materials, and Supply Chain Management
    2017 - 2018
  • Universidade Federal do Ceará
    Bachelor's degree, Pharmacy
    2013 - 2017

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