Regulatory & Site Activation Specialist - Poland

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.

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 requirements
• Coordinate and execute Essential Document Package (EDP) activities, including: Collection, review, and tracking of essential documents
• Quality control (QC) of site and regulatory documents
• Ensuring completeness and readiness for regulatory green light
• Manage communication with sites to support document collection, submissions, and activation timelines
• Liaise with Ethics Committees, Competent Authorities, and internal stakeholders to facilitate approvals
• Support responses to RFIs (Requests for Information) and manage submission follow-ups
• Maintain and update CTMS, TMF, and tracking systems with accurate and timely information
• Review and ensure readiness of site activation packages / Green Light Packages
• Track and report site activation progress, timelines, and KPIs
• Ensure all activities are performed in compliance with ICH-GCP, EU CTR, and Polish regulatory requirements

Requirements

• Based in Poland with strong knowledge of the local regulatory environment
• Bachelor's degree in Life Sciences or related field
• Polish language fluency (required) and strong English skills (written and spoken)
• 2-4+ years of experience in Regulatory Affairs, Study Start-Up, or Site Activation Experience working in a local Polish regulatory role within a CRO or sponsor
• Proven experience with: EU CTR submissions (Part II) in Poland, Country-level ICF adaptations, Essential Document Package (EDP) / activation package management, CTIS system usage, Regulatory green light / site readiness processes
• Strong understanding of clinical trial start-up workflows and regulatory timelines
• Experience interacting with sites, Ethics Committees, and regulatory authorities
• Ability to manage multiple sites and competing timelines effectively
• High attention to detail, strong organizational skills, and a proactive working style
• If this role sounds of interest, please apply today!
• #LI-DNP
• #LI-CES
• #LI-HCPN
• #LI-NS1

Benefits

Additional Information

Regulatory & Site Activation Specialist - Poland (Home-Based) Location: Poland (home-based) Contract type: Freelance/B2B contract FTE: 1.0 Start: Immediately Duration: approx. 3 months

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