Job Description

Regulatory Affairs Manager CMC - Berkshire, UK

Regulatory Affairs CMC Manager to work on biological products in development for a successful Biopharmaceutical company based in the South East, M4 Corridor.

The location is easily commutable by train from London, Reading, High Wycombe, and Windsor and is easily accessible by car with company car parking available.

This role offers great projects to work on a real career development plan designed to give you all the experience you need to make the jump up to Snr Manager Regulatory Affairs CMC.

Our client is a leading, science-based Biopharmaceutical company with some exciting new products coming in Phase 2 and Phase 3, as well as a busy early development pipeline. This company has already grown to become a major research driven organization and are committed to increasing access to high-quality healthcare products around the world. This company is now expanding their Regulatory CMC team globally and is seeking to hire a Regulatory Affairs CMC Manager.

What would your duties be?

• As a Regulatory Affairs CMC Manager you will be working on a variety of projects. Based on your strengths and experience you would either be supporting a new MAA/BLA for a product in Phase 3 or working on working on CTAs/IMPDs for biologics in early development.
• You will have both strategic and operational input for a variety of projects, potentially from early phase through to MAA as part of the Global Regulatory Affairs CMC development team.

Specific skills and competences:

• It is essential to have at least 4 – 5 years of Regulatory Affairs CMC experience supporting and authoring RA CMC documents for mAbs, vaccines, recombinant proteins, Cell Therapies or ATMP’s etc. Some IMPD/IND experience is necessary. Initial MAA experience for a biological dug candidate will be an advantage.
• You would be a good communicator who is also eager to learn and develop.
• Experience in direct communication with the Health Authorities on CMC matters.

This is a permanent opportunity and the salary is very competitive and includes a good bonus and an extensive company benefits package. There is also good flexibility to work 2 – 3 days a week from home (during normal circumstances).

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.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384. 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.

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