Regulatory Affairs Trainee

2 meses atrás

Lisboa, Portugal Servier Tempo inteiro

**Date posted**:Mar 12, 2024**City**:Lisbon**Country/Region**:PT**Type of Contract**:Intern**Job Requisition ID**:5536Regulatory affairs trainee
- Procuramos um **Regulatory affairs Trainee** para Lisboa, Portugal para apoiar o desenvolvimento das actividades do nosso departamento Farmacêutico e Assuntos Regulamentares da Subsidiária Portuguesa, a fim de maximizar o sucesso comercial e o acesso do doentes ao portfólio do Grupo.**Sobre nós**
- Somos um Grupo farmacêutico global governado por uma Fundação sem fins lucrativos, com sede em Suresnes, França. Contando com uma presença geográfica sólida e uma receita de € 5,3 bilhões em 2023, alcançada em 150 países, empregamos 21.900 pessoas em todo o mundo.- Líder em cardiologia, a nossa ambição é tornarmo-nos um player de renome e inovador na Oncologia. O nosso crescimento assenta numa aposta sustentada nas doenças cardiovasculares e metabólicas, oncologia, neurociência e doenças imuno-inflamatórias.- Todos os colaboradores do Grupo são movidos por Valores partilhados e guiados por uma Visão comum. Juntos, partilhamos a paixão pelo empreendedorismo e estamos empenhados com o progresso terapêutico para atender às necessidades dos doentes.- A Servier é certificada como Great Place To Work em Portugal.**Responsabilidades**
- Apoiar a preparação, submissão e gestão de processos de Autorização de Introdução no Mercado de Medicamentos
- Entender e apoiar o processo de Submissão para Introdução de novos medicamentos
- Zelar pela Conformidade Regulamentar dos produtos de acordo com as orientações recebidas
- Colaborar na actualização de informação do medicamento: RCM, FI e Rotulagem e bases de dados;
- Adquirir compreensão e contribuir para a Revisão e actualização de procedimentos (SOP)
- Acompanhar a legislação Portuguesa e Internacional e a sua aplicabilidade nas respectivas áreas terapêuticas;
- Apoiar do ponto de vista dos Assuntos Regulamentares as outras áreas de atividade da empresa
- Cumprir e apoiar os padrões de responsabilidade social corporativa, saúde, segurança e meio ambiente da empresa

**Qualificações**
- **Mestrado **em Ciências Farmacêuticas ou da Saúde;
- **ELEGÍVEL para estágio profissional **do IEFP (ATIVAR.PT);
- **Português fluente** é obrigatório assim como compreensão oral e escrita de inglês
- Conhecimento de ferramentas Office;
- Sólida comunicação escrita e verbal;
- Orientação para a colaboração;
- Boa organização e planeamento;
- Competências de análise e prioritização;
- Dê relevância aos valores corporativos da Servier.

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