We are currently seeking a Trainee Regulatory Associate to join our growing team in Colombia. Within the role, you will manage end-to-end publishing support for initial IND/NDA/MAA applications and life cycle maintenance of all applications across the globe. You will collaborate with various departments for planning, preparation, publishing, and quality control checks of submissions. Additionally, you will support the development of submission-ready documents for electronic submissions including formatting, hyperlinking and processing MS Word and Adobe Acrobat documents. You will also develop and maintain up-to-date knowledge of established agency standards and procedures for regulatory submissions, support eCTD, NeES/eSub, and Paper submissions format for global agencies, and troubleshoot document issues with Adobe Acrobat and MS Word. Furthermore, you will manage technical aspects for assigned submissions and status updates, perform quality checks on the published outputs, and ensure no unacceptable warnings and validation errors before the submission is filed with the relevant health authorities. You will also perform on-the-job training to follow the train-the-trainer model for beginners and provide QC feedback for continuous improvements. Your responsibilities will include reviewing and interpreting data to establish the system/tools required, performing data entry and quality control tasks associated with regulatory systems, and being accountable for reviewing new certificate requests and data entry in SharePoint. You will identify issues and provide input into solutions, adhere to quality control procedures, support global/local team members with data management workload, coordinate ancillary requests, liaise with suppliers, ensure the total delivery of required documents to clients, and provide support to the Regulatory team by attending and participating proactively in operational meetings. Lastly, you will project manage multiple requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real-time by pulling pending reports from systems, and escalate to the point of contact when timelines may not be reached.