Leigh Sandwell BSc

Leigh Sandwell is Director, EU/ROW Publishing Lead in Worldwide Regulatory Operations at Pfizer, based in the UK. He is highly experienced in the technical and process aspects of regulatory submissions and has responsibility for understanding submission technologies, interpreting guidance and regulatory requirements, with a key role in leading the development of Pfizer's eSubmission Strategy and implementation activities.

He joined Pfizer in 1998 as a specialist in the build of Pfizer's electronic submissions within Worldwide Regulatory Affairs, covering several roles in Regulatory Operations and then Information Management, before moving back into Regulatory Operations as the EU/Rest Of World Publishing Lead.

Leigh has been a member of the EFPIA eSubmission Focus Group since 2004. Leigh currently represents EFPIA on the eAF (electronic Application Form)/CESSP Change Advisory Board and the EU eCTD Maintenance Group, and joined ICH M8 (eCTD) in November 2010 where he is now the EFPIA Topic Lead. Leigh was previously involved in the development and implementation of PIM in Europe as a member of the EFPIA PIM Topic Group (6+ years) & PIM Core Team, and had chaired the EFPIA PIM Live Pilot Group & PIM Compatibility Working Group. He also participated in the Telematics Implementation Group for electronic submissions (TIGes) and participated in the CESP User Group on behalf of EFPIA.