Regulatory Affairs Coordinator

5 days ago


Fatih, Istanbul, Turkey Syneos Health, Inc. Full time

We are seeking a Regulatory Affairs Coordinator to join our team at Syneos Health, Inc.

In this role, you will be responsible for ensuring compliance with regulatory requirements and managing submissions, amendments, and periodic notifications required by central and local EC and RA.

You will also oversee site activation end-to-end process at country/site level, including preparing and submitting Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.

Key skills and qualifications include excellent understanding of clinical trial process across Phases II-IV and ICH GCP, good understanding clinical protocols and associated study specifications, and strong organizational skills with proven ability to handle multiple projects.

A successful Country Start-Up Specialist will also demonstrate an ability to provide quality feedback and guidance to peers, contribute to a training and Quality assurance plan within SSU, and update SOPs/WI.



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