Regulatory & Study Start-Up Lead – LATAM
1 semana atrás
Contratação efetiva para Intrials, CRO multinacional:
Principais atividades:
- Liderar estratégias e atividades regulatórias e de start-up de estudos clínicos nos países da América Latina, garantindo conformidade com diretrizes internacionais e regulamentos locais (ex: ANVISA, ISP, INVIMA, COFEPRIS);
- Atuar como ponto de contato principal com patrocinadores, gerenciando comunicações e alinhamentos durante o desenvolvimento, start-up e manutenção dos projetos;
- Supervisionar submissões regulatórias e éticas, mitigar riscos e colaborar com equipes multifuncionais ao longo de todo o ciclo do estudo clínico.
- Formação em Farmácia, Enfermagem, Biomedicina ou correlatas;
- Sólida experiência na área regulatória, em CROs ou indústria farmacêutica;
- Inglês avançado para conduzir reuniões no idioma;
- Espanhol intermediário será considerado um diferencial.
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