Job Description

Regulatory Affairs Senior Manager CMC, for NBE’s - Berkshire, UK

We have an opening for an experienced Regulatory Affairs CMC Senior Manager to work on biological products for an established and successful Pharmaceutical company based in the M4 Corridor.

Our client is a leading, science-based Pharmaceutical company with some exciting new products coming in Ph 2 and Ph 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 an experienced Regulatory Affairs CMC Snr Manager.

Location: Berkshire. 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.

What would your duties be?

• As a Regulatory Affairs CMC Senior 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 PIII or working on working on CTAs for biologics in development (IMPDs, INDs, etc.).
• You will have both strategic and operational input for a variety of projects covering the whole lifecycle, 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 5 years of Regulatory Affairs CMC experience supporting and authoring dossiers for mAbs, vaccines, recombinant proteins, Cell Therapies or ATMP’s etc.
• Experience in direct communication with the Health Authorities on CMC matters.
• You would be a good communicator who is also eager to learn and develop.
• You would have leadership and project management skills.
• Fluent English is a must as this is the business language.

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. 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 Regulatory Affairs Associate Director CMC.

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 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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