Senior Regulatory Compliance Coordinator

Há 2 dias

São Paulo, São Paulo, Brasil beBeeCountryApproval Tempo inteiro US$90.000 - US$120.000
Our organization seeks a skilled Country Approval Specialist to facilitate the activation of investigative sites for clinical trials. In this role, you will play a vital part in bringing new medicines to those who need them.
The successful candidate will be responsible for coordinating country-specific submissions, ensuring timely and accurate document preparation. They will work closely with internal teams and external partners to reduce startup timelines and exceed expectations.
Key responsibilities include:
  • Provides regulatory strategy advice to internal clients, guiding them through complex submission processes.
  • Develops and implements local submission strategies, aligning with global project objectives.
  • Coordinates projects with relevant internal departments, ensuring seamless collaboration and communication.
  • Promotes effective internal team communications and ensures that all stakeholders are aligned with submission timelines.
  • Serves as primary contact for investigators and regulatory authorities, managing submissions and ensuring timely resolution of issues.
  • Liaises within Site Intelligence and Activation (SIA) locally to ensure alignment with global project submission strategy.
  • Develops country-specific Patient Information Sheet/Informed Consent form documents, adhering to regulatory guidelines.
  • Maintains knowledge of PPD SOPs, Client SOPs/directives, and current regulatory guidelines, ensuring compliance and up-to-date expertise.

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