Tim Huke Email & Phone Number

• Currently Leading a global regulatory Publishing team with direct reports located in EU, Australia, Japan and North America• Currently leading Regulatory Submission Management Process Improvement project which is centralizing the roles and processes for submission planning, dossier management, document management, and archiving• Member of team implementing global DMS solution• Led global team in the planning and implementation of a fully integrated global regulatory submission process• Converted a $16bn company’s entire development and commercial portfolio from paper applications to eCTD• Led my team in the creation a global publishing job queue tool that was deployed to all regulatory affairs employees worldwide• Direct accountability for submission planning and regulatory publishing for large market applications to multiple health authorities (USA, EMA, HCA, TGA)• Created process for duplicating portions of BLA into MAA and Canadian NDS which reduced overall global publishing time• Expertise in a variety of eCTD publishing tools including Insight Publisher, Viewpoint, and eCTD express• Project management/coordination of submission publishing projects• Mastery of submission components/design in a compliant eCTD submission in all ICH regions

Listed skills include Ectd, Regulatory Submissions, Regulatory Affairs, Fda, and 3 others.