Regulatory Affairs Specialist

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 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. • When possible, 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.

🎯 Requirements

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science. • Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO. • Candidates must have strong experience in the regulatory process in Poland, specifically under the EU-CTR, to be considered for this role. • Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations. • Fluency in the Polish language is a mandatory requirement; working knowledge of English.

🏖️ Benefits

• Employees from all backgrounds and experiences are enabled to succeed. • Diversity and inclusion prioritized. • Cohesive and supportive teams. • Accessible leadership.