Job Description 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 - Collaborate with various departments for planning, preparation, publishing, and quality control checks of submissions - Support the development of submission-ready documents for electronic submissions including formatting, hyperlinking and processing MS Word and Adobe Acrobat documents - 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 - Troubleshoot document issues with Adobe Acrobat and MS Word and identify gaps in the submission and address with the respective client stakeholders - Manage technical aspects for assigned submissions and status updates - Perform quality checks on the published outputs, ensure no unacceptable warnings and validation errors before the submission is filed with the relevant HA - Perform on the job training to follow train the trainer model for beginners/fellow colleagues and provide QC feedback for continuous improvements - Review and interpret the data to establish the system/tools required to be populated in line with current standard operating procedures and/or business process documentation to support centralized data management team (if necessary) - Perform data entry and quality control tasks associated with regulatory systems - Accountable for reviewing new certificate requests, Data entry in SharePoint, and follow-up of cases through to completion - Identify issues and provide input into solutions. Perform retrospective remediation tasks - Adhere to quality control procedures and standards related to the systems or tools to ensure Regulatory compliance - Support global/local team members with data management workload when necessary to provide flexible support for the portfolio. - Coordinate ancillary requests in client ancillary requesting and document management systems - Liaise with suppliers (in-country offices and manufacturing sites)/legalization to obtain required ancillaries/samples - Ensure the total delivery of the required documents to clients for the required submission - Provide support to the Regulatory team on behalf of the Product Licensing support team by attending and participating proactively in every operational meeting - 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 - Escalate to point of contact when timelines may not be reached Desirable Skills and Experience - Proficient in MS Word, MS Excel, MS Access, MS PowerPoint, and Adobe Professional Bogota, Colombia Bachelor’s degree in Pharmacy/Pharmaceutical Chemistry, or life sciences related Entry Level Regulatory Affairs Full Time