Specialist, Regulatory Affairs - Poland - Remote

Worldwide Clinical Trials is a global, midsize CRO dedicated to pushing boundaries and innovating to improve lives. We are seeking a dedicated Regulatory Affairs Specialist to join our team and navigate the complex regulatory landscape, ensuring the success of our clinical trials.

Key responsibilities

• Plan, organize, and submit regulatory filings in a timely manner while tracking progress.
• Act as a point of contact for translation reviews and perform quality control of submission dossiers.
• Communicate submission status and action plans to project teams while identifying risks and mitigation strategies.
• Maintain country-specific patient information, consent forms, and drug labeling information.
• Monitor and interpret changing regulatory legislative requirements to advise the project team on regulatory strategies.

Requirements

• Degree in a medical, biological, physical, health, or pharmacy-related science.
• Minimum of three years of experience in clinical research, specifically in site activation or regulatory functions within a CRO.
• Strong expertise in the Polish regulatory process, particularly under the EU-CTR.
• Fluency in Polish and a working knowledge of English.
• Solid understanding of ICH GCP and relevant clinical research conduct guidance.

What we offer

• Opportunity to work in a diverse, inclusive, and collaborative global environment.
• Supportive team culture focused on professional growth and mentorship.
• Engagement in meaningful work that directly impacts patient lives and medical innovation.