Regulatory & Site Activation Specialist – Poland

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

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 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
• Bachelors degree in Life Sciences or related field
• Polish language fluency (required) and strong English skills (written and spoken)
• 24 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!

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IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.