Regulatory Affairs Specialist

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

📋 Description

• Collaborate with SAR colleagues to plan, organize, compile, track, and submit regulatory submissions in a timely manner.

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

• Provide local quality control of submission dossiers prior to their dispatch when necessary.

• 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 mitigation strategies.

• Whenever possible, cultivate professional relationships with both internal and external contacts to ensure the swift submission and approval of regulatory dossiers.

• Maintain country-specific patient information sheets and consent form customization texts.

• Keep country-specific drug labeling information up to date.

• Maintain Country Intelligence Pages.

• Be knowledgeable about and adhere to SOPs, ICH GCP, and applicable regulations.

• Stay updated on evolving regulatory legislative requirements and manage the regulatory intelligence database.

• Advise the SAR project team on suitable regulatory strategies.

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

• Provide timely updates and communicate changes in the regulatory landscape to the Regulatory Affairs department.

• Offer guidance to the Regulatory Affairs department regarding the interpretation of new legislation, guidance, and directives.

⛳️ Requirements

• A degree with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences.

• A minimum of three years of experience in clinical research, site activation, and/or regulatory-related functions within a CRO.

• Strong experience in the regulatory process in Poland, particularly under the EU-CTR, is essential for consideration for this role.

• Solid understanding of ICH GCP, relevant clinical research conduct guidance, and country regulations.

• Fluency in the Polish language is a mandatory requirement; a working knowledge of English is also needed.

🏝️ Benefits

• Employees from diverse backgrounds and experiences are empowered to thrive.

• A strong emphasis on diversity and inclusion.

• Supportive and cohesive team environment.

• Accessible leadership.