James Hendry BA

James is a Highly motivated Regulatory Operations Professional with 17 years' experience in the industry, including 9 years at a major innovator as well as stints in outsourcing, consulting, Generic Pharma and now Nuclear Medicine.
He has Extensive hands-on experience of eCTD/NeeS Submission Publishing and Submissions Management in all global regions, as well as recruiting, managing and motivating Regulatory Operations teams as both first and second-level line manager.
He have Wide experience setting up Submissions Publishing organisations, both on and offshore, in-house and outsourced, as well as designing e-Submissions processes and tools and rolling out use of Document Management systems - all with reference to Agency guidelines and Industry Best Practice.