Senior Regulatory Coordinator

Há 3 dias

Belo Horizonte, Minas Gerais, Brasil beBeeRegulatory Tempo inteiro R$82.250 - R$116.250
Job Overview

We are seeking a skilled Regulatory Specialist to join our team. As a key member of our organization, you will be responsible for coordinating and organizing data and information required by regulatory authorities, including the preparation of study documentation and submissions.

This is an excellent opportunity for someone who is passionate about ensuring compliance with regulatory requirements and has a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.

  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate, collect, and organize data and information required by regulatory authorities.
  • Compile and prepare routine submissions filed to IRB/IEC/Third Body/Regulatory Authorities.
  • Liaise with internal and external vendors in the generation of regulatory authority submissions.
  • Perform a review of final submission documents.
  • Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.

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