About Freyr
Freyr is a integral Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.

Job Title: Clinical Trial Submissions Operations
Location: Bogota, Colombia - Remote

Role Overview
The Clinical Trial Submissions Operations role supports Clinical Trial Application (CTA) activities across EU and UK regions. The position is responsible for preparation, submission, quality control, and lifecycle management of CTA submissions through Health Authority portals, ensuring compliance with applicable regulatory requirements, timelines, and internal procedures.

Key Responsibilities
Primary Responsibilities
Prepare and submit Clinical Trial Applications (CTAs) via the EU Clinical Trial Information System (CTIS) and the UK MHRA Integrated Research Application System (IRAS)



in compliance with regulatory requirements.
Perform independent quality control (QC) of CTA submissions, including submission documents and structured data entered into Health Authority portals.
Monitor CTIS and IRAS portals during designated working hours for Health Authority notices, alerts, and correspondence, and communicate updates to relevant functional teams within required timelines.
Support CTA lifecycle activities, including preparation, submission, maintenance, responses, and archival of CTA-related documents and correspondence.
Coordinate CTA activities with cross-functional and multidisciplinary teams, acting as a central point of contact.

Secondary Responsibilities
Maintain oversight of user access and role management for CTA-related systems and tools.
Provide subject matter expertise on CTIS and IRAS portals to functional teams during CTA preparation and submission activities.
Assist in the developmen

📌 Clinical Trial Submissions Operations (Bogotá)
🏢 Freyr Solutions
📍 Bogotá