Requirements
Manage CMC Regulatory dossiers for filing in multiple countries, update for responses to health authorities, and track due dates and status. Provide status updates, hold weekly tracking meetings with Technical SMEs, and solidify review and approval processes. Schedule review timeframes and comment resolution meetings with stakeholders, and manage all documents through Veeva Regulatory Vault. Support CMC technical and regulatory teams with CMC regulatory requirements and review CMC documentation.
Description
Job Overview Use existing trackers created for the filing of CMC Regulatory dossiers to multiple countries simultaneously and updated for response to questions from health authorities to manage due dates and status of each document written for the answers Provide status updates internal and external to Dossier authoring team and Submission manager in charge of the entire response dossiers. Hold weekly tracking meetings with Technical SMEs to track progress with the delivery of the answers being written/updated Solidify review and approval process Schedule review timeframes and comment resolution meetings with Technical and Regulatory CMC stakeholders Facilitate comment resolution meetings Management of all documents through the Veeva Regulatory Vault document management system Ensure that all the documents are collected in due time.RoleIn addition to this, and depending on the actual needs of the Dossier delivery activities described above, the following activities will be part of the tasks associated with this role, as needed: Supports the CMC technical team with regard to CMC regulatory requirements Review the CMC documentation from the development teams Supports the CMC Reg team on any other suitable tasks associated with the delivery of the response dossiers.IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.