Regulatory & Site Activation Specialist

This is a fully remote position, open to applicants in Poland.

📋 Description

• Serve as the main point of contact for investigative sites in Poland, ensuring effective and proactive communication.

• Oversee and manage country-specific regulatory and start-up activities, including the site activation processes.

• Prepare, review, and submit EU CTR (Part II) applications through CTIS, ensuring adherence to Polish regulations.

• Execute and manage country-specific ICF adaptations, which include review, localization, and alignment with protocol and regulatory standards.

• Coordinate and carry out Essential Document Package (EDP) activities, including the collection, review, and tracking of essential documents; quality control (QC) of site and regulatory documents; and ensuring completeness and readiness for regulatory approval.

• Facilitate communication with sites to assist in document collection, submissions, and adherence to activation timelines.

• Collaborate with Ethics Committees, Competent Authorities, and internal stakeholders to expedite approvals.

• Aid in responding to RFIs (Requests for Information) and manage follow-ups on submissions.

• Maintain and update CTMS, TMF, and tracking systems with precise and timely information.

• Review and ensure the readiness of site activation packages / Green Light Packages.

• Monitor and report on site activation progress, timelines, and KPIs.

• Ensure all activities are conducted in compliance with ICH-GCP, EU CTR, and Polish regulatory requirements.

⛳️ Requirements

• Residing in Poland with a strong understanding of the local regulatory landscape.

• Bachelor’s degree in Life Sciences or a relevant field.

• Fluency in Polish (required) along with strong English language skills (both written and spoken).

• 2–4+ years of experience in Regulatory Affairs, Study Start-Up, or Site Activation.

• Experience in a local Polish regulatory role within a CRO or sponsor.

• Demonstrated experience with: EU CTR submissions (Part II) in Poland, country-specific ICF adaptations, Essential Document Package (EDP) / activation package management, CTIS system usage, and regulatory green light / site readiness processes.

• Strong grasp of clinical trial start-up workflows and regulatory timelines.

• Experience in engaging with sites, Ethics Committees, and regulatory authorities.

• Capability to effectively manage multiple sites and competing timelines.

• Exceptional attention to detail, robust organizational skills, and a proactive work approach.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and growth.

• Flexible working hours and the possibility of remote work.

• Comprehensive health insurance and wellness programs.