Senior Regulatory Compliance Expert

2 semanas atrás


Rio de Janeiro, Brasil beBeeCompliance Tempo inteiro
Job Overview

Our Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance. They will be responsible for collecting the required investigator and essential documents to ensure timely submission to EC/IRB/Third body/Regulatory Authority and that documentation meets applicable regulations and sponsor specifications.

Responsibilities
  • Maintain awareness of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate, collect, and organize data and information required by EC/IRB/Third body/Regulatory Authority.
  • 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 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.
  • Prevent and escalate study issues appropriately and in a timely fashion.
Qualifications
  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution, AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
  • Familiarity with investigator start-up documents and contract/budget negotiation process; previous interaction with operational project teams and investigative sites.
  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.


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