Regulatory & study start-up lead latam

3 semanas atrás


São Paulo, São Paulo, Brasil Netvagas Tempo inteiro

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.
Requisitos:
  • 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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