Compliance Expert

2 semanas atrás

Porto Alegre, Brasil beBeeRegulatory Tempo inteiro
Senior Regulatory Specialist

The role of the Senior Regulatory Specialist is to ensure compliance with regulatory requirements and guidelines in assigned countries. This involves maintaining awareness of current regulatory standards, coordinating data collection and organization, and preparing routine submissions filed to IRB/IEC/Third body/Regulatory Authorities.

This position requires a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations. The successful candidate will have experience in clinical development or start-up/regulatory process, including interaction with operational project teams and investigative sites.

The ideal candidate will be able to maintain awareness of regulatory legislation, guidance, and practice in assigned countries. They will also be responsible for ensuring all assigned start-up and maintenance activities are on track, in accordance with client expectations and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.

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 submission 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.
Requirements:
  • 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.
  • Minimum of 3 years of experience in clinical development or start-up/regulatory process.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.

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