Brian Cook Email and Phone Number

• Preparation of project regulatory documents (Chemistry, Manufacturing and Control) for submission to worldwide regulatory agencies for marketing approval of new drug applications• Responsibility for authoring responses to questions from regulatory agencies (including USA, Europe and Japan), ensuring deadlines for submissions are met• Responsibility for ensuring team delivery of key analytical results• Preparation and approval of drug substance specifications• Preparation and release of drug substance data packages required for clinical trials• Representative for area of scientific expertise on project teams• Departmental responsibility for Quality, organising and implementing audits of analytical laboratories and experimental data• Responsibility for Technical Transfer of key project knowledge from a Research & Development site to a Manufacturing site• Key role in planning and implementing the worldwide rollout of a chromatography data system including end user training, best practices and administration• GlaxoSmithKline representative at external conferences and user groups • Responsibility for departmental website authoring