Remote Otter LogoRemoteOtter

Regulatory Coordinator - Remote

Posted 9 weeks ago

Overview

This position involves assisting with clinical trial submissions to various regulatory bodies, ensuring compliance with relevant guidelines and requirements.

In Short

  • Assist with clinical trial submissions to Regulatory Authorities and Ethics Committees.
  • Ensure compliance with ICH GCP and local requirements.
  • Provide submission support throughout the lifecycle of a clinical trial.
  • Track and file documents related to submissions and activities.
  • Handle approvals, acknowledgements, and correspondence.
  • Respond to requests for information.
  • Participate in continuous improvement initiatives within the department.

Requirements

  • Knowledge of clinical trial processes and regulatory requirements.
  • Experience with document management and tracking.
  • Strong organizational skills.
  • Ability to work collaboratively in a team environment.
  • Attention to detail.

Benefits

  • Opportunity to work in a dynamic environment.
  • Engagement in meaningful projects.
  • Professional development opportunities.

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