eCTD Regulatory Submission Specialist (m/f)

Description

• Planning, compiling, coordinating and tracking eCTD submissions of EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed
• Check electronic documents and reformat to standards as required, to ensure eCTD compliance
• Be responsible for submission compilation: assigning metadata, locations within the eCTD modular structure building XML backbone, eCTD leaf titles, lifecycle operators in accordance with company procedures and standards
• Liaise with a submissions outsourcing partner on these activities when required by DRA management

• Experience in making electronic submissions in eCTD format
• Fundamental understanding of eCTD regulatory guidance in the EU
• Understanding of eCTD regulatory guidance in countries outside of EU & US (e.g. Saudi Arabia, Thailand, etc.) would be an advantage
• Fluency in English