Regulatory Expert

Há 9 horas

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$61.000 - US$107.000
Job Overview

As a seasoned Regulatory Specialist, you will serve as the primary point of contact for investigative sites during site start-up activities and maintenance. Your responsibilities will include collection of required investigator and essential documents to ensure timely submission to regulatory authorities and compliance with applicable regulations.

Key aspects of this role include:

  • Maintaining awareness of current regulatory standards related to submissions;
  • Coordinating, collecting, and organizing data and information required by regulatory authorities;
  • Compiling and preparing routine submission files to IRB/IEC/Third body/Regulatory Authorities;
  • Liaising with internal and external vendors in the generation of regulatory authority submissions;
  • Ensuring all assigned start-up and maintenance activities are on track, in accordance with client expectations and compliant with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs, and quality standards.
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;
  • 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.
Benefits

This position offers a unique opportunity to work in a dynamic environment, collaborating with cross-functional teams to drive successful project outcomes.

Others

As a key member of our team, you will have the opportunity to contribute to the development and implementation of regulatory strategies, ensuring compliance with applicable regulations and guidelines.

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