Regulatory Affairs Expert

3 semanas atrás


Fortaleza, Brasil beBeeRegulatory Tempo inteiro

Job Overview

We are seeking an experienced professional to join our team as a Regulatory Specialist. In this role, you will be responsible for maintaining awareness of regulatory legislation, guidance, and practice in assigned countries.

Main Responsibilities:

  • You will 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 as applicable.
  • Evaluate start-up and maintenance activities to ensure they meet client expectations and comply with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.

Qualifications:

  • A university/college degree in a life science or related allied health profession from an accredited institution is preferred.
  • Minimum 3 years of experience in clinical development or start-up/regulatory process.

Benefits:

This role offers a unique opportunity to work in a dynamic environment and develop your skills in regulatory affairs.



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