Experience

TDV Dental Ltda.

• Brazil
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Coordenador

  • Apr 2021 - Present



Biomateriais

• Curitiba, Paraná, Brasil

• Gerente de Qualidade e Assuntos Regulatórios

  • Jun 2020 - Apr 2021



Pharmaesthetics do Brasil

• Brazil
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Supervisor

  • Apr 2019 - Jun 2020

• Supervisor de Assuntos Regulatórios

  • Apr 2019 - Apr 2019



TDV Dental/DLA Pharma - Grupo Septodont

• Pomerode / SC

• Coordenador de assuntos regulatórios

  • Oct 2017 - Apr 2019



TDV Dental Ltda.

• Brazil
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Analista de assuntos regulatórios

  • Aug 2017 - Apr 2019

  Participation in the Development and Implementation of Regulatory Strategy. Correctly compiles applicable guidelines for the project / Consults external authorities in order to confirm the strategy / Accurately identifies short- and long-term needs / Ensures the high quality of written materials / Scrupulously analyzes risks / Formulates an organized contingency plan based on the project’s critical factors and a risk-mitigation plan Provides suitable support to stakeholders in implementing the strategy. Preparation, Submission, and Follow-up of a Regulatory File Properly documents all file data / Diligently verifies that collected data comply with the regulations in effect / Accurately analyzes and verifies file contents / Conducts proper assessments in order to anticipate questions and critical issues / Updates preclinical, clinical (efficacy and safety), and CMC (chemical-manufacturing control) data / Clearly responds to questions from regulatory authorities / Justifies position (legal, ethical, or scientific) when there are differences of opinion in connection with a request from regulatory authorities / Regularly monitors commitments/obligations in response to regulatory requirements or requests. Submits documentation to concerned authorities within prescribed timelines. Show less



Janssen-Cilag Farmacêutica

• São José dos Campos

• Lab Reviewer/Lab Structure

  • Apr 2016 - Jun 2017

  Responsible for finished product release, raw data review, application of investigational tools, analyst training, lab improvement, global standard implementation, maintenance of lab platform (equipments, reference standards, consumables), new equipments acquisition & installation, continued product assessment and reporting Responsible for finished product release, raw data review, application of investigational tools, analyst training, lab improvement, global standard implementation, maintenance of lab platform (equipments, reference standards, consumables), new equipments acquisition & installation, continued product assessment and reporting



The Janssen Pharmaceutical Companies of Johnson & Johnson

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist

  • Jun 2015 - Apr 2016

  Ensures compliance with regulatory agency regulations and interpretations / prepares responses to regulatory agencies’questions and other correspondence / organizes and maintains reporting schedules for new drug applications, legacy products / assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables and slides. / maintains and archives all regulatory documentation. Ensures compliance with regulatory agency regulations and interpretations / prepares responses to regulatory agencies’questions and other correspondence / organizes and maintains reporting schedules for new drug applications, legacy products / assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables and slides. / maintains and archives all regulatory documentation.



Janssen Supply Chain Brasil

• Janssen Pharmaceutical

• Scientist III Research & Development

  • Jun 2012 - Jun 2015

  Analytical method transfer negotiation in partnership with J&J companies across the world / planning transfer activities / responsible for development and validation of analytical methods for testing & certification of chemicals and pharmaceuticals / maintains updated metrics for method transfer execution, lab errors, analytical investigation / maintains updated lab capacity / coordinates investigational or high complexity tests with public laboratories. Analytical method transfer negotiation in partnership with J&J companies across the world / planning transfer activities / responsible for development and validation of analytical methods for testing & certification of chemicals and pharmaceuticals / maintains updated metrics for method transfer execution, lab errors, analytical investigation / maintains updated lab capacity / coordinates investigational or high complexity tests with public laboratories.