Group 10
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.
  • The ideal candidate will have both experience in product development in a technical capacity and CMC Reg experience managing Regulatory Dossiers.
  • 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.

Group 12
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
  • Degree in a relevant science/technical subject
  • Fluent in English
  • Work on US East coast time zone

121 - Dossier Delivery Regulatory CMC Project Manager