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 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 requirementsCoordinate and execute Essential Document Package (EDP) activities, including:Collection, review, and tracking of essential documentsQuality control (QC) of site and regulatory documentsEnsuring completeness and readiness for regulatory green lightManage communication with sites to support document collection, submissions, and activation timelinesLiaise with Ethics Committees, Competent Authorities, and internal stakeholders to facilitate approvalsSupport responses to RFIs (Requests for Information) and manage submission follow-upsMaintain and update CTMS, TMF, and tracking systems with accurate and timely informationReview and ensure readiness of site activation packages / Green Light PackagesTrack and report site activation progress, timelines, and KPIsEnsure 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 environmentBachelor’s degree in Life Sciences or related fieldPolish 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 sponsorProven 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 processesStrong understanding of clinical trial start-up workflows and regulatory timelinesExperience interacting with sites, Ethics Committees, and regulatory authoritiesAbility to manage multiple sites and competing timelines effectivelyHigh 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 https://jobs.iqvia.com

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.

The potential base pay range for this role, when annualized, is zł105,900.00 - zł196,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.