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Dossier Delivery Regulatory CMC Project
Il y a 4 mois
Mission:
To administratively manage the tracking, review and approval of documents through the document management system for a small molecule in Oncology.
The ideal candidate will have experience in scheduling meetings, working with large Excel data sheets, databases, and Share Points, and developing tools (PowerPoint slides, templates) to enhance and facilitate communications between members of the team. CMC Regulatory experience managing Regulatory Dossiers is desirable.
Activities and responsibilities:
- Use existing trackers created for the filing of the dossier of a small molecule in Oncology 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 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
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/Experience:
- At least 3 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
- Degree in a relevant science/technical subject
- Work on US East coast or CET time zone
Soft skills:
- Organized and independent
- Ability to manage multiple activities concomitantly
Other skills:
- Computer skills: Outlook, word, Excel, Power point, SharePoints, databases
- Language skills: Fluent in English, French is an advantage
