Job Description

About My Opportunity

My team and I would like to introduce to you an exciting opportunity with great prospect you join a mid-sized pharmaceutical company in need of a dynamic CMC Regulatory Affairs Manager based in the greater London area. There is some flexibility on home / office working (3 days home, 2 days office) and the company is based in a luxury office building in the center of London, near Covent Garden.

The organization is very reputable, with a low politics environment and well-known for putting patients first, being innovative, and thinking differently. They have an exciting and expanding range of marketed products and solid data on their projects in the pipeline. In this role you will be supporting 1st MAAs submissions, for projects that are currently in Ph. 2B-3, mainly for small molecules focused on various indications as well as new L/C for these small molecules in EU. Although this is a CMC role, you will do some Module 1 as well as support M2 and 3 for new indications and dosage forms, and a new MAA they are building now, so we are looking for someone who is more small molecule focused, and likes variety.

Your Experience & Skills

This would be for you an exciting and rewarding opportunity if you want to grow a lot and work in a smaller team which is very focused on delivery, but also friendly and supportive. You will have 3 years’ plus experience for this role and also:-

- Do you possess experience of small molecule’s CMC RA in either steriles and oral syrups?

- Have you supported line extensions applications for new strengths?

- Do you have a willingness to develop your strategic and technical mindset?

- Are you willing to contribute to build a stronger EU regulatory affairs function at a new company that welcomes all newcomers passionate about the changes they make in the lives of patients?

If your answer is YES then this is the role for you, and I would be happy to present you with more information and guide you through the process!

Package

The company is very financially stable and has decades of proven success on which their foundations lay. They offer a solid basic salary and the package also includes a very decent bonus, London car allowance and other incentives. The role itself is hybrid and will allow you to both work from home and spend time face-to-face with your colleagues on site.

To Apply!

To apply for this role, please contact me, Javier Monfort on +44 207 801 3385 or send me a copy of your updated CV to my private work email: Jmm@AdvTalent.com and I will reply by return. Me and my team will support you throughout the interview process and on-boarding experience.

GDPR & Data Protection: Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete and ’’be forgotten’’ at any time after your initial registration.