Teva Regulatory Affairs Associate 

Croatia, Zagreb 

416372685

• 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

• 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

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