Expiry Date: 26-04-2023
Categories Biotech, Regulatory Affairs
Salary: On Application
Job Type: Full Time
About my client:
This new role would appeal to you if you want to work in a smaller agile company, with 5000 employees worldwide, on a focused specialty medicines pipeline, in a company where you hob knob with everyone, not just the regs teams. You might want the freedom to work from home most of the time, but want to spend some time in the office as well.
My client is a global R&D medium-sized organization, with marketed products and a development pipeline, with more than 5K employees worldwide. They are financially stable, respectful and with well-established processes and support, in what I would describe as a low political noise environment where you will work with very focused teams to build your MAA Module 3. The culture is inclusive and you will see the EU CEO and senior stakeholders regularly in the open plan (they prefer this).
You will build MAA Module 3s for initial MAAs and Line Extensions, with the support of a friendly and very experienced Line Manager, working together on EU CMC RA submissions. If you have worked in Lifecycle, on Line Extensions and have some CMC experience this would also be useful. 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 an outstanding 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. She really knows her regs!
About the role:
Our client is looking to hire a Senior Regulatory CMC Manager who has strong experience of small molecule dosage forms (sterile and tablets) define the Regulatory CMC strategy to support IMPDs for CTAs, MAAs, Scientific Advise and product development for PiPs for the EU and selected international countries. They strive for an individual with previous experience supporting or leading a MAA build for QoS and M3, as well as managing the expectations with stakeholders, ensuring CMC RA risk mitigations and 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.
Package and Location:
The company is headquartered in Central London, and they allow 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 for this role, please contact me, Javier Monfort on +44 207 801 3385 or my colleague Ivan Nash on +44 207 801 3388 or press the red “Apply for position” button or send us an email to firstname.lastname@example.org and we will reply by return. We will support you throughout the interview 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.