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Regulatory Affairs Manager

2 meses atrás

Lisboa, Portugal Spring Professional Tempo inteiro

REGULATORY AFFAIRS MANAGER

PERFIL DA **Função**:

- Preparação e submissão de pedidos de AIM de medicamentos (procedimento nacional, MRP, DCP);
- Preparação e submissão de alterações aos termos de AIM de medicamentos (procedimento nacional, MRP, DCP);
- Atualização de bases de dados;
- Atualização de informação do medicamento: RCM, FI e Rotulagem;
- Revisão de materiais de embalagem;
- Acompanhar junto das Autoridades os processos em curso;
- Acompanhar a legislação Portuguesa e Internacional e a sua aplicabilidade no respetivo sector de atividade;
- Apoiar do ponto de vista dos Assuntos Regulamentares as outras áreas de atividade da empresa.

**Perfil do Candidato**:

- Experiência 6-8 anos em Assuntos Regulamentares;
- Licenciatura em Ciências Farmacêuticas (preferencial);
- Fluência na língua inglesa - verbal e escrita;
- Resistência ao stress e cumprimento de prazos reduzidos;
- Boa Comunicação e capacidade de adaptação;
- Boa Capacidade de gestão de projetos;
- Capacidade de Trabalho em Equipa.
- Possibilidade de regime Hibrido

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