Expiry Date: 02-03-2020
Category Regulatory Affairs
Job Type: Full Time
We have a great opportunity for a Regulatory Affairs CMC professional to work on biological products in development for an established and highly successful Biopharmaceutical company based in London, M4 Corridor.
Location: London, M4 Corridor
Our client is a leading, science-based Biopharmaceutical company that is expanding its Regulatory CMC teams across the world. They have already grown to become a major research driven organization with an impressive pipeline of over 20 molecules coming up in development. 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.
The location is easily commutable by public transport and is easily accessible by car, with company car parking available. This is a permanent opportunity and the salary package is very competitive including a good bonus and extensive company benefits.
This role offers great projects to work on and 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 in the future. Our client invests in its people and you will work with an experienced Regulatory CMC leader to help you along.
As a Regulatory Affairs CMC Senior Manager you will be working on a variety of projects. You will have both strategic and operational input covering projects in development, potentially from Phase 1 through to initial MAA in the EU and subsequently ROW.
It is essential to have at least 5 years of Regulatory Affairs CMC experience supporting and authoring dossiers for large molecules – mAbs, vaccines, recombinant proteins, Cell and Gene Therapies, ATMP’s. You will have already supported and authored IMPDs and new MAAs for such products and would like to now lead your own projects and be the responsible for the Regulatory CMC expertise in the assigned region. You will have an input into the development and implementation of global regulatory CMC strategy.
If you are looking for your next career step in Regulatory Affairs CMC within biologicals, then this may be the opportunity you have been waiting for.
We look forward to hearing from you!
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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