Dossier Delivery Regulatory Cmc Project Manager
il y a 6 jours
Responsibilities
**Mission**:
To manage the tracking, review and approval of RtQ including the management of all documents through the document management system for a small mocule in Oncoloy.
Small molecule background desirable.
**Activities and responsibilities**:
Use existing tracker created for the filing of the dossier of a small mocule in Oncoloy to multiple countries simultaneously and updated for the RtQ 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 CMC Reg stakeholders
Facilitate comment resolution meetings
Management of all documents through the document management system
Ensure that all the documents are collected in due time and are e-CTD format compliant
In 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.
Profile
Between 10 and 15 years experience
Experience in managing projects within a CMC context. Previous experience on managing projects in a CMC Technical function a plus
An understanding of the NDA structure and CTD format
An understanding of drug manufacturing and control
Organized and independent
Ability to manage multiple activities concomitantly
Fluent in English
Work on US East coast time zone
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