Regulatory Affairs Specialist, Belgian Dutch Speaker

🕒 il y a 24 jours

🌐 Belgique, France, +1 autres pays – Distant

🇧🇪 Belgique – Télétravail 🇫🇷 France – Télétravail 🇳🇱 Pays-Bas – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🚔 Conformité

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Worldwide Clinical Trials

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis • May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc. • Where required provide local QC of submission dossiers prior to dispatch • Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions • Identify risks and generate mitigation strategies • Foster professional working relationships with internal and external contacts to ensure expeditious submission/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 • Be familiar with and comply with SOPs, ICH GCP and applicable regulations • Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database • Advise the SAR project team about appropriate regulatory strategies • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements • Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department • Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives

🎯 Exigences

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science • Minimum three years of experience in clinical research, in 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 a mandatory requirement; working knowledge of English is required.

🏖️ Avantages

• Health insurance • Professional development opportunities • Flexible working hours