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 supporting continuous improvement initiatives within the department.

In Short

• Assist with clinical trial submissions to regulatory bodies.
• Act as the main point of contact for regulatory communications.
• Review and author Informed Consent Forms.
• Maintain regulatory trackers and document sharing methods.
• Participate in project team meetings and escalate complex issues.
• Oversee submissions to regional review bodies.
• Support the development of country-specific Informed Consent Forms.
• Prepare response submissions to information requests.
• Assist with ongoing department initiatives.
• Work with Line Manager to define personal goals.

Requirements

• Post-Secondary Certificate +1-3 years of experience.
• Life sciences specialty and/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.