Regulatory Affairs Associate - Poland

The Regulatory Affairs Associate supports the preparation, tracking, and coordination of regulatory submissions for clinical trials, ensuring compliance with applicable regulations and internal timelines.

Location: Poland

Responsibilities

• Assist in the compilation and preparation of documentation required for Ethics Committee (EC) and Regulatory Authority (RA) submissions.
• Support the tracking of submission timelines and maintain regulatory trackers and databases.
• Assist in the preparation and submission of initial applications, amendments, and notifications under supervision.
• Coordinate with IRB/IEC and internal teams to collect required documentation.
• Review and format documents for consistency and completeness prior to submission.
• Assist in adapting country-specific informed consent forms based on master templates.
• Coordinate translation requests and track deliverables from external vendors.
• Help submit documents to the Trial Master File (TMF) and participate in TMF reconciliation activities.
• Perform administrative tasks including document archiving, status reporting, and follow-up with sites or vendors.
• Support regulatory specialists in the review and submission of SUSARs.
• Stay informed of basic regulatory guidelines applicable to the assigned countries.
• Participate in internal meetings and training sessions.

Requirements

• Bachelor’s degree (or equivalent) in a scientific discipline.
• 0-2 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry; experience preparing and submitting IRB/IEC packages and/or CTAs.
• Knowledge of applicable regional/national country regulatory guidelines and IRB/IEC regulations is an asset.
• Excellent knowledge of Microsoft Office suite.
• Additional languages are an asset.
• Basic understanding of clinical trial processes and regulatory requirements is an asset.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Fluency in English (oral and written); additional languages are an asset.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Willingness to learn and develop regulatory expertise under guidance.

Benefits

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development