Regulatory Affairs Specialist

🕒 June 5

🇨🇿 Czechia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 55%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Liaise with SAR colleagues to plan, organize, compile, progress, track, and submit regulatory submissions • Act as a contact point for translation review of submission documents when required • Provide local quality control of submission dossiers prior to dispatch • Communicate submission status and action plans to the SAR Lead and relevant project team members • Identify risks and generate mitigation strategies • Foster professional relationships with internal and external contacts to expedite submission and approval of regulatory dossiers • Maintain country-specific patient information sheet and consent form customization text • Maintain country-specific drug labeling information • Maintain Country Intelligence Pages • Comply with SOPs, ICH GCP, and applicable regulations • Maintain regulatory intelligence database and stay informed of changing legislative requirements • Advise the SAR project team on appropriate regulatory strategies • Review relevant documentation and recommend changes for compliance with ICH GCP and country-specific requirements • Provide updates on changes in the regulatory environment to the Regulatory Affairs department • Advise the Regulatory Affairs department on interpretation of new legislation, guidance, and directives

🎯 Requirements

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science • Minimum three years of experience in clinical research, site activation and/or a regulatory-related function within a CRO • Strong experience in the regulatory process in Czechia, specifically under the EU-CTR • Good knowledge of ICH GCP, relevant clinical research conduct guidance, and country regulations • Fluency in Czech is mandatory • Working knowledge of English • Strong organizational and management skills • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills • Self-motivated learning about current regulatory processes and intelligence • Excellent written and verbal communication skills • Team-oriented work style • Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment • Excellent ability to handle multiple tasks in a fast-paced and changing environment • Proficiency in Microsoft Word, Excel, PowerPoint, and all MS-Office applications • Aptitude for contemporary digital systems is helpful

🏖️ Benefits

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law • Supportive and cohesive teams • Diverse and inclusive work environment • Remote work arrangement