Regulatory Affairs Specialist, Belgian Dutch Speaker

This is a fully remote position, open to applicants in Belgium, +2 more countries.

📋 Description

• Collaborate with SAR colleagues to strategize, organize, compile, progress, track, and ensure timely submission of regulatory documents.

• Serve as the primary contact for the review of translated submission materials, including applications, synopses, ICFs, and labels.

• When necessary, provide local quality assurance for submission dossiers prior to dispatch.

• Update the SAR Lead and relevant project team members on submission status and action plans.

• Identify potential risks and develop mitigation strategies.

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

• Keep the country-specific patient information sheet and consent form customization text up to date.

• Ensure the accuracy of country-specific drug labeling information.

• Maintain the Country Intelligence Pages.

• Adhere to SOPs, ICH GCP, and relevant regulations.

• Monitor evolving regulatory legislative requirements and manage the regulatory intelligence database.

• Provide guidance to the SAR project team on suitable regulatory strategies.

• Review and suggest modifications to labels, patient information sheets, diary cards, and other relevant documentation.

• Inform the Regulatory Affairs department about changes in the regulatory landscape.

• Counsel the Regulatory Affairs department on the interpretation of new legislation, guidance, and directives.

⛳️ Requirements

• Bachelor's degree with a focus in medical, biological, physical, health, pharmacy, or a related scientific field.

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

• Extensive knowledge of the regulatory process in Poland, particularly under the EU-CTR.

• Strong understanding of ICH GCP, relevant clinical research guidance, and country-specific regulations.

• Proficiency in Flemish (Belgian Dutch) is essential.

• Working knowledge of English is required.

• Competence in Microsoft Word, Excel, and PowerPoint.

• Exceptional organizational, planning, strategizing, management, monitoring, scheduling, and analytical skills.

• Outstanding written and verbal communication abilities.

• Strong interpersonal skills in a dynamic, deadline-driven environment.

• Capability to manage multiple tasks in a fast-paced and evolving setting.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and collaborative team environment.

• Accessible leadership.

• Equal employment opportunities.

• Exceptional employee experiences.