Regulatory Affairs Associate

Job Summary

A company is looking for a Regulatory Affairs Associate in Poland.

Key Responsibilities

• Assist in the preparation and submission of documentation for Ethics Committee and Regulatory Authority submissions
• Support tracking of submission timelines and maintain regulatory trackers and databases
• Coordinate with internal teams and external vendors to collect required documentation and manage administrative tasks

Required Qualifications

• Bachelor's degree (or equivalent) in a scientific discipline
• 0-2 years of experience in clinical regulatory affairs in the pharmaceutical, biotechnology, or CRO industry
• Knowledge of regional/national regulatory guidelines and IRB/IEC regulations is an asset
• Basic understanding of clinical trial processes and regulatory requirements is an asset
• Fluency in English; additional languages are an asset