Regulatory Cmc Ra Associate Director Cell Therapy
hace 2 semanas
I am looking for a pioneer, someone who likes true innovation and wants to work in a small, highly focused team, to bring a Ph 1/2 product, into Ph 3 and beyond, and has the educational / scientific and regulatory background to lead this NME, a cell therapy, for CMC M3, before, the IMPDs, and the EOP1/2 Scientific Advice procedures.
You will relish this type of challenge
You will report to an individual who has worked in this therapy area for many years, as their counterpart, you will support all things CMC, and they are supporting the overall regulatory strategy.
What is good about this organization, is, although you are joining a high science high technology team, but they are part of a much bigger organization, with many marketed products in-line, and have the funding and money to see this Cell Therapy through development and into registration and launch.
You will have experiences in:
- Developing IMPDs for Cell Therapy products in the European region
- Working with Contract Development Manufacturing organizations or partners
- Understand the technology platform associated with Cell therapies
- Have strong influencing and communication skills and be able to work with people from different cultures and backgrounds
- Want to see a project through the development phases
- Have experience of supporting ATMPs, through at least 1 or 2 clinical phases or have registered an ATMP
The role can be based at a number of European offices with semi remote working also available, locations include the UK (Hertfordshire), France (Paris), Germany (Munich), Switzerland (Geneva), Netherlands (Amsterdam), Poland (Warsaw) and Spain (Madrid).
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To Apply_**
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