Regulatory Submissions Specialist (m/f)

Description

• Collaborate with DRA Project Leaders, submission teams and DRA Editorial Group on planning, coordinating and tracking eCTD submissions for EU procedures, providing eCTD expertise where required to ensure all submissions are effectively executed
• Work with the Regulatory Operations group in New Jersey to contribute to overall planning activities, including US-generated submissions
• As required, provide support to the Regional Management Group for eCTD/NeeS submissions
• Publish documents for electronic submissions in eCTD format using appropriate tools
• 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
• Be responsible for quality control of the submission, its contents and backbone, both manually and through appropriate validation software applications
• Act as the Data Entry Responsible for the Regulatory Management System (RMS) in line with the relevant quality system documents

• Experience in making electronic submissions in eCTD format
• Fundamental understanding of eCTD regulatory guidance in the EU
• Experience with electronic document management systems
• Experience using a Regulatory Information Management System (RIMS)
• Excellent Acrobat skills and experience in electronic publishing of documents
• Knowledge of ISIToolbox, XML and of eCTD Submissions
• Understanding of eCTD regulatory guidance in countries outside of EU and US
• Ability to communicate effectively in English (spoken and written)