Karin Rombouts

Biography

Responsible for overall strategic Global Regulatory Affairs input into the Disease Area Team strategies and ensure alignment with individual project strategies via the compound specific Global Regulatory Leaders. Ensure the regulatory strategies throughout the lifecycle of a compound. Integrates multiple inputs from regional and functional Global Regulatory Team members to create coherent and unified global regulatory strategies. Leads Global Regulatory Team, represents Global Regulatory Affairs and provides regulatory expertise on the Compound Development Team. Leads the preparation of regulatory dossiers for submission to Health Authorities. Establishes Rapid Response Teams to develop and obtain alignment on global strategy for responses to Health Authorities. Works with the Global Regulatory Team to provide input for target labeling and the Labeling Working Group in making strategic decisions, including the creation of Labeling strategy.

Research Interest

During the development of a new chemical entity (new compound that can lead to a new drug), providing strategic input, cross-functional operational management and leadership to the Compound Development Team, including facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making. Developing and managing cross-functional project timelines, resources, and budget. Managing project information and communication including access to project/team documentation