Regulatory Affairs Specialist

Há 4 dias

Brasil beBeeRegulatory Tempo inteiro US$80.000 - US$100.000

Job Overview:

The primary contact with investigative sites during start-up activities and maintenance involves collecting required investigator and essential documents to ensure timely submission of EC/IRB/Third Body and Regulatory Authority applications. This role requires interaction with regulatory authorities to provide guidance on requirements and maintain awareness of current standards.

Key Responsibilities include:

  • Maintain knowledge of regulatory legislation, guidance, and practice in assigned countries.
  • Coordinate collection and organization of data and information required by regulatory bodies, including preparation of study documentation.
  • Compile and prepare routine submissions filed to IRB/IEC/Third Body and Regulatory Authorities, liaising with them as applicable.
  • Liaise with internal and external vendors for regulatory authority submissions.
  • Perform review of final submission documents.
  • Ensure assigned start-up and maintenance activities are on track, meeting client expectations and regulatory requirements.

Required Skills and Qualifications:

  • University degree (life science preferred) or certification in a related allied health profession, along with 2 years' work experience in clinical research.
  • Strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
  • Familiarity with investigator start-up documents and contract/budget negotiation process.
  • Previous interaction with operational project teams and investigative sites.

Benefits:

  • General Office Environment.

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