Andreia Viana

Regulatory Affairs Officer at Labatec Pharma SA
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Contact Information
us****@****om
(386) 825-5501
Location
Lisboa, Lisbon, Portugal, PT
Languages
  • Portuguese Native or bilingual proficiency
  • French Full professional proficiency
  • English Professional working proficiency

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Experience

    • Switzerland
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Officer
      • May 2020 - Present

      - Submission of new Marketing Authorisations in Switzerland;- Management of Post-Marketing Authorisation life cycle in Switzerland;- Support to MENA regulatory team;- Due diligence to new products.

    • Portugal
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Officer
      • Apr 2017 - May 2020

      - Preparation of dossiers (modules 1, 2 and 3) for Marketing Authorisation Applications in accordance with regulatory requirements (in EU and non-EU territories);- Management of Post-Marketing Authorisation life cycle through submission of variations (CMC/Safety/Administrative) and renewals to competent authorities worldwide;- PIL and Labelling artworks management.

    • Portugal
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Pharmacist
      • Nov 2015 - Nov 2017

      - Pharmaceutical activities of dispensing medicines;- Development of health promotion actions;- Work environment under philosophy KAIZEN.

    • Portugal
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Project Manager - QA/ RA
      • Feb 2017 - Apr 2017

      - Registration of Class I medical devices.

    • Portugal
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Medical Affairs Officer
      • Jan 2015 - Oct 2015

    • Customer Relationship Manager
      • Jun 2014 - Dec 2014

    • Hospital Pharmacist
      • Feb 2013 - Aug 2013

      - Quality control of prescriptions of narcotic and psychotropic drugs;- Medication reconciliation in the geriatric unit.

Education

  • Faculdade de Direito da Universidade de Lisboa
    Post-graduation, Medicines Law
    2018 - 2019
  • CESIF
    Master's degree, Pharmaceutical Industry
    2013 - 2014
  • Universidade Lusófona de Humanidades e Tecnologias
    Master's degree in Pharmaceuticals Sciences
    2008 - 2013

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