Bovine TB vaccine Consultant

Description

To provide ongoing regulatory consultancy for the CattleBCG vaccine programme . Movement into this final and critical phase of the project makes it imperative that continuity of advice is with someone well-versed with the work undertaken to-date. This contract will provide regulatory support to the TB cattle vaccine field trial project and ongoing regulatory oversight to construction of the Market Authorisation (MA) Dossier submissions to VMD for the licenced use of BCG and the companion DIVA test in the UK. Providing specialised and technical advice on the requirements for: • Negotiations with commercial GMP providers • Providing specialised and technical advice on the design and execution of vaccine research and development • Licensing of a vaccine for cattle with associated DIVA diagnostic test for use in the Cattle Tuberculosis Eradication Strategy throughout UK licensing of vaccines; and • The regulation and commercialisation of cattle vaccine and related in-vivo and in-vitro diagnostic assays.