Regulatory Affairs Manager EU/UK CTA/CTR - london
Freyr Solutions • london, Canada
Role Description
Job Title: Clinical Trial Submissions (CTS) Strategy Support
Location: Remote
Employment Type: Permanent/Full-Time
Role Overview
The Clinical Trial Submissions (CTS) Strategy Support provides operational and strategic support to CTS Strategy Leads in the planning and execution of Clinical Trial Authorization (CTA) submissions. The role involves document tracking, cross‑functional coordination, and ensuring timely delivery of submission components in compliance with EU/UK Clinical Trial Regulations and ICH‑GCP guidelines.
Key Responsibilities
Primary Responsibilities
- Support CTS Strategy Leads in preparation, quality control (QC), and compilation of CTA submission documents.
- Track document provision activities, including proactive follow‑up with stakeholders and CROs to ensure timely delivery.
- Maintain detailed trackers for CTA submission deliverables and timelines.
- Support preparation of meet...