Regulatory & Site Activation Specialist

IQVIA

Regulatory & Site Activation Specialist focusing on regulatory submissions and site activation processes in Poland's clinical trials. Engaging with sites and ensuring compliance with local regulations.

Posted 6/9/2026contractRemote • 🇵🇱 PolandJuniorMid-Level💰 PLN 105,900 - PLN 196,600 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account IQVIA Website LinkedIn All Job Openings 10,000+ employees ⚕️ Healthcare Insurance 🧬 Biotechnology 🤖 Artificial Intelligence 💰 $1G Post-IPO Debt on 2023-05 Healthcare Insurance
Biotechnology
Artificial Intelligence IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients. Regulatory & Site Activation Specialist 🔥 36 minutes ago 🇵🇱 Poland – Remote 💵 zł105.9k - zł196.6k / year ⏳ Contract/Temporary 🟢 Junior 🟡 Mid-level 🚔 Compliance 🗣️🇵🇱 Polish Required Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Compliance Analyst I 🕒 May 28 Affirm 1001 - 5000 💳 Fintech 👥 B2C 🛍️ eCommerce Website LinkedIn All Job Openings Financial Crimes Analyst supporting financial compliance at Affirm. Working with financial crimes team and regulatory requirements. 🇵🇱 Poland – Remote 💵 zł149k - zł179k / year 💰 Post-IPO Equity on 2021-01 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Regulatory Compliance Analyst 🕒 September 25, 2025 McCormick & Company 10,000+ employees 🛍️ eCommerce Website LinkedIn All Job Openings Regulatory Compliance Analyst at McCormick managing product regulatory information, approvals, labeling and commercialization support. Liaises with international teams and leads regulatory projects. 🇵🇱 Poland – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Regulatory Compliance Analyst 🕒 August 11, 2025 McCormick & Company 10,000+ employees 🛍️ eCommerce Website LinkedIn All Job Openings Regulatory Compliance Analyst at McCormick; remote from Poland. 18-month maternity cover contract. 🇵🇱 Poland – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Food Regulatory Compliance Analyst 🕒 July 21, 2025 McCormick & Company 10,000+ employees 🛍️ eCommerce Website LinkedIn All Job Openings Join McCormick as a Regulatory Compliance Analyst managing compliance and quality assurance projects remotely from Poland. 🇵🇱 Poland – Remote ⏳ Contract/Temporary 🟢 Junior 🟡 Mid-level 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

EU CTR submissionsICF adaptationsEssential Document Package managementCTIS system usageregulatory green light processesclinical trial start-up workflowsregulatory timelinesdocument collectionquality control of documentssite activation package management

Soft Skills

communicationorganizational skillsattention to detailproactive working styleability to manage multiple sitesinterpersonal skillsleadershipproblem-solvingtime managementcollaboration