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.
• 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.