Job Description

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 communication
  • Lead and manage country-level regulatory and start-up activities, including site activation processes
  • Prepare, review, and submit EU CTR (Part II) applications via CTIS, ensuring compliance with Polish regulations
  • Perform and manage country-specific ICF adaptations, including review, localization, and alignment with protocol and regulatory requirem...

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