How you’ll spend your day
Prepare, publish and dispatch eCTD (CTD) lifecycle management submissions, ensuring that all final electronic deliverables meet current regulatory electronic document requirements and guidance
Archive published dossiers and administrative data according to the internal processes
Accurately and timely updating internal working schedules, related to assigned task
Troubleshoot submission and document issues
Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions
Develop and maintain working knowledge of internal and external publishing standards
Work with the Manager to ensure completion of tasks within agreed timelines
Other assignments as required
Your experience and qualifications
Master's Degree (preferred in Life Sciences or Information Technology)
Experience in the Pharmaceutical Industry in Regulatory Operations/Regulatory Affairs is a plus
Experience in publishing regulatory submissions and using regulatory e-submission software is a plus (Veeva)
Basic understanding of processes and departments within a pharmaceutical company is a plus
Good knowledge of MS Office Suite and Adobe Acrobat
Fluent English
Ability to multi-task, pay close attention to detail, and follow projects through to completion
Ability to work under pressure and to tight time deadlines
Effective time and organisation management
