http://www.pharmiweb.com/careers/results.asp?ROW_ID=250198

Director, European Regulatory Affairs, UK

Job Summary

Medpace, Inc. is a global contract research organization (CRO) with headquarters in Cincinnati, Ohio USA that manages clinical trials for pharmaceutical companies. For more information about Medpace, please visit our website at www.Medpace.com.

Requirements:

We are looking to further expand our global operations by establishing a regulatory affairs office in the UK .  We are seeking an individual to fill the role of the Director of European Regulatory Affairs, in the UK area, in order to facilitate this development.  This individual will be responsible for setting up the office, managing day to day operations, and hiring and training of new regulatory employees.  In addition, this individual will need to build relationships with clients, and Medpace staff in other parts of the world.  Some of the other responsibilities will include leading the coordination, preparation, and assembly of Clinical Trial Applications and Central Ethics Committee Submissions; providing regulatory advice and guidance to project teams to ensure submissions meet European regulatory requirements;   reviewing marketing submissions for European regulatory compliance and accuracy; serving as primary liaison between the company and European Regulatory Authorities for individual projects; preparing for key meetings with the Regulatory Authorities; providing European regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents; and maintaining up-to-date knowledge of European regulatory requirements. This position will initially be a home-based position until the office is established.  Candidates must have a minimum of 8 years of experience in European regulatory affairs, preferably with business management experience.  An advanced medical/clinical related degree is required.  The position will report directly to the Global Director, Regulatory Affairs, based in Cincinnati , Ohio .  All interested candidates should e-mail their resume and cover letter by using the Click Here to Apply  button.

http://www.pharmiweb.com/careers/results.asp?ROW_ID=250198