Senior Regulatory Affairs Expert

Há 22 horas

Belo Horizonte, Brasil Caderno Nacional Tempo inteiro

Senior Regulatory Affairs Expert - Detalhes da Vaga. ? 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. ? . Requisitos para participar do processo. ? . O que oferecemos.

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