Your role

On regulatory submissions/operations:

• Administer and Monitor Regulatory Operations systems (e.g. docuBridge, Veeva) and ensure they are being managed properly and working in compliance with existing regulations

• Work closely with Clinical and CMC Regulatory Affairs, cross-functional teams and relevant vendors to provide operational oversight and support for the planning, preparation, tracking, and timely submission of all regulatory applications and updates to global health authorities (e.g. IND, NDA, MAA, post approval submissions

• Assist in planning, execution and tracking of regulatory submissions in timely manner within RIM system including compilation and publishing of electronic regulatory applications, mainly in the eCTD format

• Serve as a point of contact for regulatory publishing activities; ensure all formatting and document completeness

• Report to Regulatory Leads on deliverables for major milestone submissions

• Manage use of Regulatory Operations tools (e.g. SharePoint, Adobe, Acumen Stylus) for record management and publication

• Archive regulatory submission packages within Veeva RIM

• Maintain and review records and data in the RIM system

On Publishing system (docuBridge): 

• Compile eCTD submissions according to health authority guidelines and ITM internal standards
• Assist the docuBridge Business Administrator with software maintenance activities, including software updates, data migration, system configuration, and day-to-day business support

On internal processes:  

• Support development of internal process documentation including SOPs, work instructions, and best practices on regulatory information system and regulatory publishing topics