Associate Director Regulatory Affairs CMC ** Work on a 1st filing of a NCE ** Greater London Area

Reference: ISJ516

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 medium-sized global pharmaceutical company, with small, friendly, and highly focused teams working together to bring the pipeline in development through clinical stages and first market authorization. Their hub is based in London, and they have other affiliate sites across Europe covering their late phase programs for Ph 2/3 IMPDs, MAA and preparation of Module 2/3.

To support these new chemical entities, my client is looking to hire an Associate Director in regulatory CMC, that will be responsible for the regulatory CMC strategy and pre-subs for these products that include different dosage forms and are anti-infectives, tablets, some sterile injectables and peptides for rare diseases.

They are not a start-up and have established processes and support, to help you build your MAA Module 3, in a company which I would describe as friendly, respectful, and stable and with focused teams 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.

You will have IMPD and MAA QoS and M3 build experience and be prepared to lead sub projects for a filing in preparation under the guidance and support of the Director and the Head of Regulatory CMC. The role is working on small molecules drugs in development, so I would like to present you this opportunity to be working on CMC Module 3 for late phase compounds for you to demonstrate your expertise in MAAs or major Line Extensions and IMPDs for innovative products.

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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