| Title | : Regulatory Specialist (Full-Time) |
| Department | : Clinical Operations |
| Reporting Position | : Regulatory Manager |
| Location | : Ankara (On-site) |
The Regulatory Specialist supports the effective execution of the legal and ethical processes in clinical trials. Key responsibilities include preparing and revising Ethics Committee submission files, managing official correspondence, and ensuring compliance with Ministry of Health notifications and relevant regulations when required. The role also covers coordinating and completing Site Coordinator authorization processes, as well as maintaining close communication with sponsors. In addition, the Regulatory Specialist monitors updates in relevant regulations, informs project teams, and ensures that all processes progress accurately and in a timely manner.
Key Responsibilities
Actively supporting the preparation and presentation of Site Coordinator Ethics Committee submissions
Following up on correspondence, approval processes, and required notifications
Monitoring regulatory updates and sharing them with the project team
Supporting processes of observational studies and liaising with investigators
Archiving clinical trial documents and managing related documentation processes
Coordinating Site Coordinator authorization processes with
relevant internal personnel, providing reminders and guidance when necessary
Communicating with sponsors regarding Site Coordinator presentations, ensuring timely delivery of documents, follow-up, and use of electronic archiving systems when required
Must Have
Bachelor’s or Master’s degree in health sciences, biology, pharmacy, chemistry, molecular biology, biomedical engineering, nursing, or related fields
Preferably familiar with regulatory processes in clinical trials, or motivated to develop in this area
Knowledge of ICH-GCP and relevant regulations
Strong written and verbal communication, attention to detail, and strong follow-up skills
Proficiency in MS Office applications
Strong presentation skills and ability to represent in formal settings such as Ethics Committees
Commitment to keeping up to date with regulatory developments