About Freyr
Freyr is a global 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 development and maintenance of regulatory operations work instructions and procedural documentation.
- Perform User Acceptance Testing (UAT) for submission management tools, as required.
- Participate in evaluations of new technologies supporting Regulatory Operations needs.
- Stay current with evolving regulatory requirements and industry standards.
Qualifications & Experience
Education
- Bachelor’s degree in Life Sciences or a related discipline, or equivalent experience.
Technical Skills
- Working knowledge of EU Clinical Trial Regulation (CTR) and UK Clinical Trials regulations, including The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019.
- Hands-on experience preparing and submitting regulatory applications via Health Authority portals (CTIS and/or IRAS).
- Experience supporting regulatory applications such as Clinical Trial Applications (CTAs).
- Familiarity with Electronic Document Management Systems (Documentum-based systems preferred).
- Proficiency in Microsoft Office Suite (Word, Excel, Access, PowerPoint) and SharePoint.
Soft Skills
- Strong attention to detail and accuracy in data entry and procedural execution.
- Ability to manage time-sensitive, detail-intensive deliverables.
- Strong communication and coordination skills in cross-functional environments.
- Ability to adapt to changing regulatory and operational requirements.
Why Freyr?
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.