Trainee Regulatory Associate

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