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.
  • Work collaboratively within the department.
  • Maintain timely documentation and filing processes.
  • Support the overall conduct of clinical trials.

Requirements

  • Experience with clinical trial submissions.
  • Knowledge of ICH GCP guidelines.
  • Strong organizational skills.
  • Attention to detail.
  • Ability to work under deadlines.
  • Excellent communication skills.
  • Familiarity with regulatory processes.
  • Team player mentality.
  • Proficiency in document management.
  • Commitment to compliance and quality.

Benefits

  • Opportunity to work in a dynamic environment.
  • Professional development opportunities.
  • Collaborative team culture.
  • Contribution to important clinical research.
  • Potential for career advancement.
  • Comprehensive benefits package.
  • Flexible working arrangements.
  • Supportive management.
  • Access to training resources.
  • Engagement in continuous improvement efforts.

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