Senior Regulatory Affairs Expert

Há 2 dias

Belo Horizonte, Minas Gerais, Brasil beBeeRegulatory Tempo inteiro US$70.000 - US$85.000
Job Description

As a Regulatory Specialist, you will serve as the primary point of contact for investigative sites during site start-up activities and maintenance. Your responsibility will be to collect and organize data and information required by regulatory authorities, including the preparation of study documentation.

Key Responsibilities:

  • Maintain awareness of current regulatory standards and legislation in assigned countries.
  • Coordinate and collect data and information required by regulatory authorities.
  • Compile and prepare submission documents, such as country application forms and cover letters.
  • Liaise with internal and external vendors regarding regulatory submissions.
  • Review final submission documents for accuracy and compliance.

Additionally, you will 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.

Required Skills and Qualifications:

  • University/College degree in life science or certification in a related allied health profession, AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budget negotiation process; previous interaction with operational project teams and investigative sites.

Benefits:

  • Opportunity to work in a dynamic and fast-paced environment.
  • Chance to develop your skills and expertise in regulatory affairs.
  • Collaborative and supportive team environment.

Others:

  • Fortrea offers a competitive compensation package and comprehensive benefits program.
  • Ability to work in a global setting with diverse cultures and environments.

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