Sven E.

WORK HISTORY

EDUCATION

ABOUT SVEN E.

In my current role within the Regulatory Documentation Management department, part of Regulatory Affairs Innovative Medicines at Teva GmbH, I manage and enhance our internal databases while providing comprehensive support for upcoming submissions. I developed the in-system process and I am Subject Matter Expert (SME) for Notified Body Opinion Interactions. I have initiated the creation of video instructions to improve process awareness among our team. Additionally, I utilize our system\'s reporting tool to analyze metadata and deliver detailed monthly reports to management. With a professional background in data science, statistics, and medicine, I excel at solving complex problems. My expertise includes planning and evaluating clinical studies, working with databases and information systems, programming, and data protection. Key-Roles: Process Development and Subject Matter Expert (SME) for Notified Body Opinion Interactions - Process Optimization:~ Lead the development and enhancement of processes for the Veeva Documentation System, ensuring efficient and effective use across the organization- Standardization:~ Drive the harmonization of processes and standards within Regulatory Affairs (RA) to ensure compliance and consistency- Strategist Support:~ Provide expert support to RA strategists, ensuring the preparation of high-quality, submission- ready documents- Regulatory Expertise:~ Maintain and apply comprehensive knowledge of medical device regulations to support notified body submissions. EU Clinical Trial Applications SME- Define processes and provide technical support in clinical trial applications. Global Regulatory Documentation SME- Manage global documentation, ensuring version control and compliance for submissions- Develop and implement dossier strategies and content plans for global regulatory activities. Dossier Management SME- Support RA strategists and authors with system training and problem-solving- Coordinate with R&D and site RA teams for dossier compilation and metadata management- Act as a gatekeeper for system integrity and data consistency. Business SME for Veeva Documentation System- Define and optimize RA processes, ensuring seamless integration and operation within the Veeva system- Ensure the integrity and accuracy of document metadata post-migration.