Senior Regulatory Specialist

4 semanas atrás

Fortaleza, Brasil beBeeRegulatory Tempo inteiro
Job Overview

Our team is seeking a highly skilled Senior Regulatory Professional to join our global organization. As a key member of our regulatory group, you will be responsible for ensuring compliance with all applicable regulations and guidelines.

The ideal candidate will have a strong understanding of regulatory legislation, guidance, and practice, as well as excellent communication and interpersonal skills. They will be able to work effectively in a fast-paced environment and prioritize multiple tasks and projects simultaneously.

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  • Key Responsibilities:
  • Coordinate and collect data and information required by regulatory authorities;
  • Prepare and compile routine submissions filed to IRB/IEC/Third body/Regulatory Authorities;
  • Perform quality reviews 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.
Qualifications

To be successful in this role, you will need the following qualifications:

  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.

Desirable Qualifications:

  • 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.
  • Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.
Experience

Minimum of 3 years of experience in clinical development or start-up/regulatory process.

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