Director Compliance role at Manulife managing the Complaints & Regulatory Investigations team. Overseeing investigations and ensuring compliance with regulatory standards.
About the role
- Regulatory Affairs Assistant focused on pharmaceutical-related logistics at PINEX. Engaging in regulatory analysis, documentation, and compliance monitoring.
Responsibilities
- Realizar análise de documentos e processos regulatórios.
- Manter-se atualizado sobre as normas e legislações pertinentes ao setor.
- Participar de reuniões e interagir com órgãos reguladores, quando necessário.
- Contribuir para a implementação de boas práticas regulatórias na empresa.
- Elaborar documentação regulatória necessária para a submissão inicial e manutenção dos processos regulatórios dos projetos de programas assistenciais de acesso a medicamentos.
- Monitorar a condução de programas assistenciais junto ao centro de pesquisa.
- Contatar diretamente a ANVISA e outros órgãos anuentes por e-mail, telefone, peticionamento eletrônico ou outro canal, para submeter processos, para realizar consultas e monitorar tramitação dos processos.
- Monitorar o fluxo logístico dos produtos relacionados aos programas assistenciais.
Requirements
- Curso superior na área da saúde, concluído ou em progresso (como Farmácia e Biomedicina);
- Inglês intermediário/avançado;
- Espanhol básico;
- Conhecimento da legislação e procedimentos burocráticos e logísticos de assuntos regulatórios;
- Conhecimentos básicos de produtos de cadeia fria;
- Cursos complementares que são diferenciais:
- Cursos na área de assuntos regulatórios, comércio exterior e/ou logística, além de especializações, workshop, cursos e treinamentos nas áreas de Pesquisa Clínica.
Benefits
- Assistência médica
- Assistência odontológica
- Cesta de natal
- PLR
- Seguro de vida
- Vale refeição
- Vale transporte
- Plano de carreira
- Day Off
- Parceria com o Senac
- Parceria com o Sesc
- WellHub
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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