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Regulatory Affairs Officer

4 semanas atrás

Rio de Janeiro, Brasil Servier Tempo inteiro
Elaborar e submeter processos de registro, pós registro de medicamentos, produtos para saúde ou cosméticos, incluindo levantamentos, elaboração de justificativas técnicas, discussões, trocas e alinhamentos com as áreas envolvidas (matriz, indústria, clínica, médica, etc);
- Elaborar os processos de alteração/notificação de textos de bula e rotulagem dos produtos sempre que necessário, comunicando às áreas impactadas sobre essa mudança, além de acompanhar a disponibilização das novas versões no site da empresa;
- Elaborar e submeter processos de farmacovigilância com relatórios PBRER e Planos de Minimização de Riscos;
- Organizar os arquivos de documentos já submetidos às Autoridades Sanitárias (físico e eletrônico) em respeito à legislação em vigor, manter os respectivos sistemas internos e planilhas de controle atualizados no que tange as datas submissões/aprovações de processos submetidos e demais informações cabíveis;
- Acompanhar status de processos já submetidos pelo site da ANVISA, pelo Diário Oficial da União e pelas demais publicações sobre as novas regulamentações, ficando responsável por compartilhar com a equipe de regulatórios, liderando as discussões sobre o impacto das mesmas;
- Participar de cursos, reuniões, workshops sobre temas relacionados à Assuntos Regulatórios, visando contribuir com novas ideias que possam agilizar a aprovação de registros pela ANVISA;
- Dar suporte aos estagiários e jovens aprendizes nas atividades a eles designadas, com relação aos processos regulatórios, exercitando sua liderança;
- Elaborar processos de certificação de centros de bioequivalência e de plantas fabris internacionais e nacionais (Boas Práticas de Fabricação) a fim de manter os processos da empresa atualizados;
- Revisão de materiais promocionais/médicos/formação quanto ao cumprimento dos requisitos de propaganda dispostos na regulamentação da ANVISA e Código de Conduta da Interfarma.
- Revisão de estudos pós mercado, tais como pesquisa de mercados, estudos iniciados por investigadores, registros e outros quanto ao cumprimento dos requerimentos locais para tais estudos e informações aprovadas do produto.
- Avaliação de impacto e abertura de controle de mudanças no escopo de suas atividades.
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.