Sara Barbosa

Regulatory Affairs Officer at Phagecon - Pharmaceutical Services and Consulting
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Contact Information
us****@****om
(386) 825-5501
Location
Portugal, PT
Languages
  • Inglês Professional working proficiency
  • Português Native or bilingual proficiency

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Experience

    • Portugal
    • Pharmaceuticals
    • 1 - 100 Employee
    • Regulatory Affairs Officer
      • Apr 2021 - Present

      − Regulatory affairs consultant on the following areas: Human Medicinal products: MA Applications under different types of procedures (NPs, MRPs, DCPs in the EEA) and legal basis, Variations, transfers and Renewals under the different types of procedures (NPs, MRPs, DCPs) ; - Preparation and revision of texts for SPC, PIL and Labelling; - Preparation and monitoring of regulatory processes for Medicinal Products in the United Kingdom and Swizerland; - Preparation, submission and management of Marketing Authorization Applications; - Instruction and monitoring of price requests, annual review of prices and temporary reductions; Instruction and follow-up of reimbursement request; - Registration of Food Supplements in third countries. Show less

    • Cyprus
    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Regulatory Affairs Officer
      • Dec 2021 - Jun 2022

      On behalf of Phagecon On behalf of Phagecon

    • Portugal
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Jan 2019 - Mar 2021

      • Regulatory support in the development of new food supplements and cosmetic products • Regulatory support to the commercial, production and purchasing department • Artwork verification (cartons and leaflets) from a technical and regulatory point of view and clients’ support in the development of artworks, taking into account the legislation in force; • Monitoring the life cycle of several products, with special emphasis on food supplements and cosmetic products. • Registration of food supplements and cosmetic products with the respective Competent Authorities / notification platforms • Export documentation preparation and contact with Competent Authorities as well as relevant institutions (Embassies, Chambers of Commerce, etc.) Show less

    • Pharmacy Technician
      • Nov 2018 - Jan 2019

    • Internship
      • Mar 2015 - Jul 2015

      Participation on a research group with emphasis for carrying out activities related with HPLC method validation, analysis of analytes and data base creation. Participation on a research group with emphasis for carrying out activities related with HPLC method validation, analysis of analytes and data base creation.

    • Portugal
    • Hospitals and Health Care
    • 700 & Above Employee
    • Internship Student
      • Dec 2014 - Jan 2015

      Developed activities related with the handling of cytotoxic drugs Developed activities related with the handling of cytotoxic drugs

  • Farmácia Gare do Oriente
    • Lisboa e Região, Portugal
    • Internship Student
      • Oct 2014 - Dec 2014

Education

  • Faculdade de Farmácia da Universidade de Lisboa
    Advanced Cosmetology Postgraduate Course (Part 1)
    2019 - 2019
  • Escola Superior de Tecnologia da Saúde de Lisboa
    Curso Atualização em Assuntos Regulamentares em Farmácia, 17
    2020 - 2020
  • Faculdade de Farmácia da Universidade de Lisboa
    MSc Pharmaceutical Regulatory Affairs, Pharmacy
    2015 - 2018
  • Escola Superior de Tecnologia da Saúde de Lisboa
    Licentiate degree, Pharmacy
    2011 - 2015

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