Regulatory Affairs Specialist, Belgian Dutch Speaker

🔥 0 minutes ago

🌐 Belgium, Netherlands, +1 more countries – Remote

🇧🇪 Belgium – Remote 🇳🇱 Netherlands – Remote 🇫🇷 France – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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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 on time • Act as a contact point for translation review of submission documents, including applications, synopses, ICFs, and labels • Provide local quality control of submission dossiers before dispatch when required • 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 • Track changing regulatory legislative requirements and maintain the regulatory intelligence database • Advise the SAR project team on appropriate regulatory strategies • Review and recommend changes to labels, patient information sheets, diary cards, and other documentation • 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 regulatory-related function within a CRO • Strong experience in the regulatory process in Poland, specifically under the EU-CTR • Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations • Fluency in Flemish (Belgian Dutch) is mandatory • Working knowledge of English is required • Proficiency in Microsoft Word, Excel, and PowerPoint • Strong organizational, planning, strategizing, management, monitoring, scheduling, and critiquing skills • Excellent written and verbal communication skills • Strong interpersonal skills in a fast-paced, deadline-oriented, changing environment • Ability to handle multiple tasks in a fast-paced and changing environment

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Exceptional employee experiences