Regulatory Affairs Specialist

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

📋 Description

• Collaborate with SAR team members to plan, organize, compile, monitor, track, and submit regulatory submissions promptly.

• May serve as a point of contact for the review of translation for submission documents including applications, synopses, informed consent forms, labels, etc.

• Provide local quality control for submission dossiers prior to their dispatch as needed.

• Communicate effectively with the SAR Lead and relevant project team members regarding the status and action plans related to submissions.

• Identify potential risks and develop strategies for mitigation.

• Cultivate professional relationships with both internal and external stakeholders to facilitate the swift submission and approval of regulatory dossiers.

• Maintain country-specific patient information sheets and the customization text for consent forms.

• Review and provide recommendations on all relevant documentation, such as labels, patient information sheets, and diary cards to ensure compliance with ICH GCP and country-specific regulations.

⛳️ Requirements

• A degree majoring in medical, biological, physical, health, pharmacy, or another related science.

• At least three years of experience in clinical research, particularly in site activation and/or regulatory functions within a CRO.

• Extensive knowledge of the regulatory process in Czechia, especially under the EU-CTR.

• Strong understanding of ICH GCP, relevant clinical research conduct guidelines, and national regulations.

• Proficiency in the Czech language is essential; a working knowledge of English is also required.

🏝️ Benefits

• A diverse and inclusive work environment.

• Opportunities for professional development.