Location: Bogota,NJ, USA
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