Regulatory Affairs Associate

This is a fully remote position, open to applicants in Poland.

📋 Description

• Assist in gathering and preparing the necessary documentation for submissions to the Ethics Committee and Regulatory Authority.

• Monitor submission timelines while managing regulatory trackers and databases.

• Aid in the preparation and submission of initial applications, amendments, and notifications under supervision.

• Collaborate with IRB/IEC and internal teams to obtain required documentation.

• Review and format documents to ensure consistency and completeness prior to submission.

• Customize country-specific informed consent forms based on master templates.

• Coordinate translation requests and track deliverables from external vendors.

• Submit documents to the Trial Master File and engage in TMF reconciliation activities.

• Handle document archiving, status reporting, and follow-up with sites or vendors.

• Assist regulatory specialists in reviewing and submitting SUSARs as needed.

• Stay updated on basic regulatory guidelines pertinent to assigned countries.

• Take part in internal meetings and training sessions.

⛳️ Requirements

• Bachelor’s degree (or equivalent) in a scientific field.

• 0-2 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, and/or CRO industry.

• Experience in preparing and submitting IRB/IEC packages and/or Clinical Trial Applications (CTAs).

• Familiarity with relevant regional/national regulatory guidelines and IRB/IEC regulations is advantageous.

• Strong proficiency in Microsoft Office Suite.

• Excellent command of Microsoft Office applications (Word, Excel, Outlook).

• Fluency in English, both spoken and written.

• Proficiency in additional languages is a plus.

• Basic understanding of clinical trial processes and regulatory requirements is beneficial.

• Exceptional attention to detail and strong organizational abilities.

• Capable of managing multiple priorities and meeting deadlines in a dynamic environment.

• Eagerness to learn and develop regulatory expertise under guidance.

• Legally authorized to work in Poland.

🏝️ Benefits

• Permanent full-time position.

• Flexible scheduling options.

• Vacation time.

• Home-based work opportunity.

• Continuous learning and development opportunities.

• Attractive opportunities for career advancement.