Regulatory Coordinator - Remote

Overview

The Regulatory Coordinator will assist with clinical trial submissions to Regulatory Authorities and ensure compliance with ICH GCP and local requirements, while also supporting continuous improvement initiatives within the department.

In Short

• Assist with clinical trial submissions to regulatory bodies.
• Ensure compliance with ICH GCP and local regulations.
• Act as the main point of contact for regulatory communications.
• Maintain study regulatory trackers and document sharing methods.
• Participate in project team meetings and escalate complex issues.
• Oversee submissions to regional review bodies.
• Develop country-specific Informed Consent Forms.
• Support mitigation of regulatory risks.
• Assist with ongoing department initiatives.
• Work with Line Manager to define personal goals.

Requirements

• Post-Secondary Certificate with 1-3 years of experience.
• Life sciences specialty or Regulatory designation preferred.
• Attention to detail and adaptability.
• Basic understanding of regulatory submission requirements.
• Basic understanding of ICH-GCP.
• Resourceful in sourcing regulatory requirements.
• Proficient in Microsoft Word, Excel, PowerPoint.

Benefits

• Home-based working conditions.