Charge affaires règlementaires Cmc

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