Regulatory Affairs & Safety Manager

• Lead the planning and execution of the Regulatory Affairs & Safety activities
• Ensure the regulatory process for clinical trial submission is planned and executed including management of the Clinical Trial Application documentation for international Phase I-III clinical trials
• Handle document writing and collection, and coordinate submissions with multiple global stakeholders
• Be the main responsible for global trials submissions covering phase 1-3
• Coordinate interactions with national and international Regulatory Agencies and Independent Ethics Committees regarding new and existing clinical trials
• Prepare Safety Management Plans in collaboration with internal and external stakeholders
• Process Serious Adverse Events from Investigator sites, including handling, review and querying
• Responsible for complete and accurate safety data collection and registration of adverse events
• Completion and submission of expedited safety reports from our clinical trials to Competent Authorities and Independent Ethics Committees in accordance with local and global regulations
• Keep up with updated regulatory requirements and continuously adapt our procedures to be fit for purpose
• Maintaining regulatory and safety parts of our Clinical Trial Master Files
• Engaging in correspondence with Sponsors, Contract Research Organizations and other Vendors

• Educational degree in health sciences
• Experience interacting with competent authorities concerning clinical trials or marketed products
• Familiarity with GCP, clinical trials, eTMF, and/or safety databases
• Fluent in business English (both oral and written)
• Basic medical writing skills
• Solid project management skills

Familiarity with GCP, clinical trials, eTMF, and/or safety databases

Opportunity to work remotely two days a week