Regulatory Affairs Specialist – German Speaker

This is a fully remote position, open to applicants in Germany, +1 more country.

📋 Description

• Collaborate with SAR colleagues to plan, organize, compile, track, and submit regulatory documents promptly.

• May serve as a point of contact for translation reviews of submission documents, including applications, synopses, informed consent forms (ICF), labels, etc.

• Provide local quality control for submission dossiers before dispatch when necessary.

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

• Identify potential risks and develop mitigation strategies.

• Whenever feasible, build professional relationships with internal and external contacts to facilitate timely submission and approval of regulatory dossiers.

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

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

• Oversee the maintenance of Country Intelligence Pages.

• Ensure familiarity with and adherence 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 recommend changes to all pertinent documentation, such as labels, patient information sheets, and diary cards, ensuring compliance with ICH GCP and country-specific regulations.

• Provide timely updates and communicate any 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 focus in medical, biological, physical, health, pharmacy, or another related field.

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

• Strong expertise in the regulatory processes in Germany and Switzerland.

• Comprehensive knowledge of ICH GCP, relevant clinical research conduct guidelines, and country regulations.

• Fluency in German is essential; a working knowledge of English is also required.

🏝️ Benefits

• Global team events.

• Opportunities for professional development.

• A diverse and inclusive workplace.