Expiry Date: 28-09-2021
Category Regulatory Affairs
Job Type: Full Time
Windsor and Maidenhead
Global Regulatory CMC Lead, GRL CMC, Associate Director - biologic orphan drugs
The location is Berkshire, UK (M4 Corridor). On offer is an excellent financial opportunity and a level of work flexibility post Covid 19.
This will be a Global role, covering the EU, USA and other key markets.
Our client develops rare disease/orphan drugs, aiming to connect patients living with severe and chronic conditions, to cutting-edge science, and in doing so make a real difference to people with unmet needs. This company is structured to develop new medicines, and innovative approaches to quickly deliver therapeutics to provide meaningful advances to patients.
This is a rare opportunity to join a fast-growing Biopharmaceutical company, where you can make a real difference leading high profile projects. It will be challenging, but nevertheless a career-making opportunity.
Regulatory CMC experience with biologics is required for this role - and in particular monoclonal antibodies (mAbs) is ideal.
In this role you will be responsible for the regulatory CMC Strategy of key products, and be part of the senior team setting the Global Regulatory Strategy for the company. Here you will manage a small team of Regulatory CMC Scientists and lead projects in development (Phase I to Phase III), initial MAA/NDA registrations as well as follow through with post-marketing activities. This role will be a combination of Strategy and hand-on project/product management.
The ideal candidate will have 10 years plus in Regulatory CMC in both Biologics and Phama. Experience with Regulatory Strategy, tactics and implementation, Scientific Advice meetings with the EMA/FDA etc. is necessary. Project leadership skills are vital here, along with solid background of doing the heavy lifting – authoring / writing sections of regulatory CMC dossiers for biologic products (IMPDs, INDs, initial MAA/BLAs, as well as module 3 for major Variations).
Interested in the above?
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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