Regulatory Coordinator - Remote

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 attention to detail and organizational skills.
• Ability to work collaboratively in a team environment.
• Excellent communication skills.

Benefits

• Opportunity to work in a dynamic environment.
• Professional development opportunities.
• Contribute to important clinical research.