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
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
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.
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
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
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.