Director Global Regulatory Affairs CMC ** Work on a 1st Filing on a NCE in EU ** Greater London Area

Reference: ISJ515

Expiry Date: 20-12-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Greater London

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Job Description

My client is a global R&D medium-sized organization, with more than 5000 employees worldwide and a solid count of marketed products in EU. They are financially stable, respectful and with established processes and support, in what I would describe as a low political environment where you will work with very focused teams to build your MAA Module 3.

They are not a start-up and have established processes and support, to help you build your MAA Module 3, in a company which is friendly and has their teams working together on EU CMC RA submissions. The line manager is an Executive Director who has a track record of preparing and fling MAAs in EU for NMEs and a lor of experiences to share to help guide your success in this agile global pharma.

The company is headquartered in London, and they are looking to hire a Director of RA CMC who has matrix management experience and can lead a NCE into Module 3 build and submissions for the EU and selected international countries. Our client looks for an individual that has previously managed FTEs, with experience leading a MAA build for QoS and M3, as well as managing the expectations with stakeholders, ensuring CMC RA risk mitigations, planning and support to the Therapy Regulatory Lead during final submission and review periods.

The role is mainly focused on development and hence you will not be working on mature products or life cycle management, however you will support the line extensions of your assigned programs after your 1st MAA approvals registration.

Our client allows home working model for a major part of the time and will not ask you to be in the office more than 1-2 days a week. They are offering a competitive salary for UK standards and the role comes with a very decent bonus and company benefits.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Javier Monfort on +44(0) 207 801 3385, or send a full CV to and I will be happy to discuss the role further and give you more information. As we know the hiring manager, we will support you throughout the interview and on-boarding experience.

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