Regulatory Affairs, CMC Global Regulatory Leader - Berkshire, UK

Reference: TM10481G

Expiry Date: 20-12-2020

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory Affairs, CMC Global Regulatory Leader - Berkshire

Do you want to take the lead for global biological development projects?

This is a rare and unique role where you can take the lead for Global registrations for Biological products in mid and late stage development through to registration and Global expansion!

My client is a Global Biotechnology company with a pipeline of nearly 20 indications in development, with 5 major product registrations planned in the next 2-3 years. They are recruiting for a bright and ambitious Regulatory CMC professional to take the lead on developing global regulatory CMC strategies for mAbs in development guiding them through both EU and US registrations.

Location: Berkshire, easily commutable via car or public transport.

This highly efficient and extremely successful medium sized Biotechnology company has developed a hugely impressive pipeline of large molecule biologicals in mid and late stage of development. There are a number of potential blockbusters due for filling in the EU and USA over the next 1-3 years. As a result my client is now seeking a highly experienced CMC professional with a biological background gained through experience in either EU or US markets to take the lead in setting global strategies and coordinating complex submissions for the US, Europe and major markets.

This is a highly visible role that requires strong levels of leadership for multiple cross-functional project teams and strong organizational and analytical skills to drive and provide strategic / operational regulatory CMC direction. 

Your duties will include responsibility for leading global CMC regulatory strategy for biologic development of projects and marketed products.  This will include HA meetings and negotiations for FDA and EMA. You will also lead and matrix manage for internal & external teams on assigned projects for the preparation and review of IND/IMPDs, NDA/BLAs and EU and International MAAs.

With this excellent role comes an excellent package which includes: a high level basic salary, bonus, car allowance, full re-location package to Berkshire with expectations that you will take the lead for Global projects.

You must have knowledge of working within European Regulatory Affairs specifically as applied to biotechnology products.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo or Oli on +44 (0)207 801 3384 or +44 (0)207 801 3388 . All applications are received in confidence! ADV Talent Partners will help you each and every step of the way through the hiring process!

Note: My client has committed to do digital hiring using Skype (VC), and has a new digital on-boarding and induction training process in place to allow a smooth transition during MERS-COV-2 outbreak. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

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.