Sara Barbosa
Regulatory Affairs Officer at Phagecon - Pharmaceutical Services and Consulting- Claim this Profile
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Inglês Professional working proficiency
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Português Native or bilingual proficiency
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Bio
Experience
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Phagecon - Pharmaceutical Services and Consulting
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Portugal
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Pharmaceuticals
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1 - 100 Employee
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Regulatory Affairs Officer
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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
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Medochemie Ltd
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Cyprus
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Regulatory Affairs Officer
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Dec 2021 - Jun 2022
On behalf of Phagecon On behalf of Phagecon
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Lecifarma - Laboratório Farmacêutico, Lda.
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Portugal
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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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
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Pharmacy Technician
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Nov 2018 - Jan 2019
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Hostess
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2014 - 2018
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CEDOC - Chronic Diseases Research Center FCM NOVA
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Lisboa e Região, Portugal
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Internship
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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.
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Hospital da Luz
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Portugal
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Hospitals and Health Care
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700 & Above Employee
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Internship Student
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Dec 2014 - Jan 2015
Developed activities related with the handling of cytotoxic drugs Developed activities related with the handling of cytotoxic drugs
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Farmácia Gare do Oriente
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Lisboa e Região, Portugal
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Internship Student
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Oct 2014 - Dec 2014
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Education
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Faculdade de Farmácia da Universidade de Lisboa
Advanced Cosmetology Postgraduate Course (Part 1) -
Escola Superior de Tecnologia da Saúde de Lisboa
Curso Atualização em Assuntos Regulamentares em Farmácia, 17 -
Faculdade de Farmácia da Universidade de Lisboa
MSc Pharmaceutical Regulatory Affairs, Pharmacy -
Escola Superior de Tecnologia da Saúde de Lisboa
Licentiate degree, Pharmacy