A Regulatory Submissions Assistant is required for an initial 3-month contract. As the successful candidate, you will have experience with electronic publishing and strong knowledge of eCTD requirements. The role requires document management experience or information technology experience with emphasis in submission/report publishing and project leadership. High proficiency in publishing tools such as Documentum, ISI eCTDXpress, Adobe Acrobat, and expert knowledge of WORD and EXCEL. Applicants must have demonstrated organisation skills and ability to work independently. You will have strong oral and written communication skills and will be a self-starter and team player. Responsibilities include document formatting support provided to global Regulatory Affairs regulatory executives (Therapeutic Groups, Discovery Regulatory, NonClinical Regulatory and CMC Regulatory). You will be required to publish regulatory authority specific documentation for delivery to markets using sophisticated, validated, purpose-developed electronic documentation software. The successful candidate will also be responsible for support of global CMC processes or systems used to support global CMC regulatory activities. For additional information and a confidential discussion, please contact Trish Kelly at Hays on 020 3465 0045.