Törzskönyvezés állások, munkák

• Nemzetközi törzskönyvi kérelmek összeállítása összhangban a jelenlegi tendenciákkal és a jogszabályi változásokkal
• A regisztrációs törzskönyv összeállítása és értékelése a regisztrációs követelmények szerint
• Készítmények törzskönyvezése, törzskönyvi módosítása, fenntartása

• Gyógyszerek hazai és nemzetközi törzskönyvezési, módosítási és megújítási eljárásainak előkészítése és lebonyolítása (OGYÉI, MRP/DCP).
• Törzskönyvi dokumentációk (CTD modulok) összeállítása, ellenőrzése, hiánypótlások és hatósági válaszok előkészítése.

• Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
• Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.

• Du hast zum Zeitpunkt des Praktikums das Studium der Pharmazie mit dem 2. Staatsexamen erfolgreich abgeschlossen.
• Eine sorgfältige und gewissenhafte Arbeitsweise, Zuverlässigkeit und Teamfähigkeit zeichnet dich aus.
• Im Umgang mit MS Office und MS Outlook bist du versiert.

• Regulatory assessment of raw materials, recipes and nutrient profiles
• Creation and updating of regulatory documentation (e.g. list of ingredients, nutrition information, raw material information)
• Review and approval of labels and communication materials in accordance with EU food law

Define and Execute Strategy: Establish and drive the global regulatory strategy for the Pharmaceutical Business Unit, ensuring direct alignment with our commercial objectives and Testo's 2030 vision....

Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery...

Point of contact for Regulatory Affairs colleagues with focus on Latin America regarding product registrations, including guidance on responding to deficiency letters and regulatory authority inquiries...

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

• Collect data and prepare progress reports, KPIs, and metrics for regional and global reporting, including monthly reports, management reviews, and quarterly quality reports.
• Support ad hoc global quality reporting by gathering data and providing contextual insights to regional QA Senior Management.

• Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
• Manage the development and implementation of RA strategies
• Support and prepare product submission documents with main focus on US
• Partner with business stakeholders on different levels

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.