Regulatory / Regulatory Affairs Senior Manager CMC, for NBE’s - Based in Maidenhead

Reference: Oli10481

Expiry Date: 18-11-2019

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

Regulatory / Regulatory Affairs Senior Manager CMC, for NBE’s - Based in Maidenhead

Location: Maidenhead, Berkshire

We have a great opportunity for a Regulatory Affairs CMC professional to work on biological products (mAbs) for an established and highly successful Biopharmaceutical company based in the M4 Corridor.

Our client is a leading, science-based Biopharmaceutical company that is expanding its R&D pipeline and has already grown to become a major research driven organization. Over the years our client has brought some state-of-the-art medicines from the laboratory to the patient. They have some exciting new products coming in Phase II, Phase III and a number of products in early development and are committed to increasing access to high-quality healthcare products around the world.

The location is easily commutable by train from London, Slough, Reading, High Wycombe, and Windsor and is easily accessible via car with company car parking available. This is a permanent opportunity and the salary is very competitive and includes a good bonus, car allowance and an extensive company benefits package and 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.

As a Regulatory Affairs CMC Senior Manager you will be working on a variety of projects. In effect we have 3 roles open, so based on your strengths and experience you could be supporting a new MAA/BLA for a product in PIII or / and working on lifecycle management activities for established biologic for market expansion projects in the EU and ROW. There is also an opportunity to support projects in early development (PI, PII).

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.

If you are looking for your next career step in Regulatory Affairs CMC within Biologicals in a broad based and varied role, then this may be the opportunity you have been waiting for.

You will have both strategic and operational input for a variety of projects covering the whole lifecycle, potentially from Phase 1 through to MAA as part of the Global Regulatory Affairs CMC development team.

 

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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