Regulatory Affairs Specialist - Czechia - Remote

Worldwide Clinical TrialsPrague, CzechiaremoteSalary not postedView the original posting at Worldwide Clinical Trials ↗

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! Make an Impact as a Regulatory Affairs Specialist at Worldwide Regulatory Affairs is at the heart of bringing clinical research forward, helping ensure studies progress efficiently while meeting complex regulatory requirements. In this role, you will play a key part in supporting clinical trial submissions and approvals across Czechia, contributing to the successful delivery of innovative medical research. Working closely with global project teams and regulatory experts, you will help drive submission strategies, maintain compliance with evolving regulations, and provide valuable regulatory guidance throughout the study lifecycle. Your expertise will directly support the timely activation and conduct of clinical trials that advance patient care. You will also serve as a trusted resource for regulatory intelligence, helping teams navigate country-specific requirements while fostering effective collaboration with internal and external stakeholders. Where You'll Work This is a remote role open to candidates based in Czechia. You will collaborate with global teams across multiple time zones. No travel is required for this position. What You'll Do Coordinate and manage regulatory submissions, ensuring dossiers are compiled, tracked, and submitted within agreed timelines. Review submission-related documents and support translation review activities to ensure accuracy and compliance with local requirements. Perform quality control checks on submission packages before submission when required. Communicate submission status, risks, and mitigation plans to regulatory leads and project teams. Advise project teams on appropriate regulatory strategies and country-specific requirements throughout the study lifecycle. Maintain country-specific regulatory intelligence, including consent form text, patient information documents, drug labeling information, and intelligence resources. Monitor changes in the regulatory environment and provide timely updates to stakeholders and the wider Regulatory Affairs team. Review study documentation to ensure compliance with ICH GCP, EU-CTR requirements, and country-specific regulations. Build effective working relationships with internal and external stakeholders to support efficient regulatory approvals. What You'll Bring Degree in medical, biological, physical, health, pharmacy, or another related scientific discipline. Minimum 3 years of experience in clinical research, site activation, and/or a regulatory affairs function within a CRO environment. Strong experience managing regulatory processes in Czechia, including demonstrated knowledge of EU Clinical Trial Regulation (EU-CTR). Solid understanding of ICH GCP, clinical research regulations, and country-specific regulatory requirements. Excellent organizational, planning, prioritizati

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