About the Role
We are looking for a Regulatory & Site Activation Specialist based in Poland to support local clinical trial start-up activities with a strong focus on regulatory submissions and site activation. This role will act as a country-level regulatory start-up expert, ensuring compliant and timely submissions, effective site communication, and readiness for site activation under EU CTR and Polish regulatory requirements.
Key Responsibilities
Act as the primary point of contact for investigative sites in Poland, ensuring clear and proactive communicationLead and manage country-level regulatory and start-up activities, including site activation processesPrepare, review, and submit EU CTR (Part II) applications via CTIS, ensuring compliance with Polish regulationsPerform and manage country-specific ICF adaptations, including review, localization, and alignment with protocol and regulatory requirem...