The Regulatory CMC Division of our client is looking for a Senior CMC Reg Consultant .
Mission:
To manage and deliver the CMC Dossier (relevant section of Modules 1, Module 2.3 and Module 3) for the initial submission in EU & the first line international countries for a small molecule product in development.
This includes the management of all documents through the document management system.
Activities and responsibilities:
- Provide CMC Regulatory support to the CMC Technical team in relation to the EU requirements & the requirements for the first lin international countries - Compile regulatory documents in support of submission on time and in line with EU requirements - Identify rate limiting deliverables and interdependencies with other sections - Provide status updates to Dossier authoring team and Submission manager as needed - 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 - Represent Regulatory CMC within the CMC development team and other transversal teams - Advise CMC members with regard to CMC regulatory requirements - Write or review the CMC documentation from the development teams - Organize the schedule of deliverables (sections of the dossier) with the development teams - Manage responses to questions from the authorities Profile/Experience:
- 8 - 10 years of experience - Experience in managing the delivery of late phase CMC Regulatory documents for EU submission and the first line international countries - Organized and independent - Ability to manage multiple activities concomitantly - Degree in a relevant science/technical subject - English:
read, written, spoken - Taste of contacts and teamwork - Oral and written communication skills - Experience in project management is a plus IvidataLifeSciences Essonne Expérience souhaitée
