Brussels Metropolitan Area
Global Regulatory Lead in Clinical Nutrition Therapeutic Area: - Develop and execute regulatory plans for complex projects including new product development and lifecycle management of sterile drug products - Represent the RA function on assigned cross-functional project teams for the portfolio - From 2025 to 2026, actively participated in implementation of Veeva Vault RIM Suite for IDMP implementation
Global Regulatory Lead in Clinical Nutrition Therapeutic Area, in charge of the Devices group for Electromechanical, Software and Disposable products: - Develop and execute regulatory plans for complex projects including new product development, EU Medical Device Regulation (MDR) and CE-marking of non-Medical Device equipment - Represent the RA function on assigned cross-functional project teams for the portfolio - Oversee group activities, project assignment and prioritization - From 2020 to 2023, actively participated in implementation of Veeva Vault RIM Suite (Registrations, Submissions and Submission Archives), migration of existing data from Register and FirstDoc to Veeva Vault, development of internal processes and best practices for international adoption by the RA community and supporting functions
Global Regulatory Lead in Clinical Nutrition Therapeutic Area, in charge of the Micronutrients and Devices group: - Develop and execute regulatory plans for complex projects including new product registration and maintenance of licenses - Represent or lead the RA function on assigned cross-functional project teams - Oversee group activities, project assignment and prioritization
- Clinical trial regulatory submissions in EU (Phase III-IV) - Lifecycle management of biological product family in Europe, CIS and Central & South America - CMC compliance - Development and implementation of a process for EU xEVMPD data collection and upload into EMA's database
- Registration of a radiopharmaceutical product through a European Decentralised Procedure - Adapting Quality/CMC documentation from US dossier (NDA and SNDA) to CTD format for EU - Lifecycle management of a radiopharmaceutical product registered via European Mutual Recognition Procedure - Insourcing of eCTD publishing (using eCTD Office) and development of eCTD-compliant templates
Research question: What are the REACH Regulation proposal and its impact for the industry? - Analysis of the draft Regulation proposal - Authoring of flowcharts breaking down the different decision trees, processes, and related actions described in the draft Regulation - Creation of a bilingual (French-English) web-interface to facilitate the navigation between created flowcharts, summaries of important items and full regulatory texts.