The Senior Regulatory Associate, Regulatory Affairs, Strategic Global Labeling- Operations assists with creation and maintenance in prescription drug, over the counter (OTC), cosmetic and/or device product labeling in Regulatory Information Management and global labeling systems to meet regulatory requirements. Actively contributes to the development and implementation of product labeling for marketed products and for monitoring the labeling activity in the RIM system for products and ensuring the completeness and accuracy of RIM data. Works with Strategic Global Labeling and submission teams to provide appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in the RIM system, as described in functional area procedures; and is responsible for managing product drug listings (US SPL and CA SPM) and products in development. Serves as regulatory labeling operations representative on relevant project teams.  Independently performs job tasks and interfaces with cross-functional groups as needed. 

Responsibilities: 

•Assists with creating ores and maintaining product labeling in the RIM global labeling systems including redlined, proposed and cumulative labeling documents. 

•Represents Strategic Global Labeling- Operations in cross-functional meetings regarding business processes and implementation of RIMGLS system updates. 

•Demonstrates ability to use electronic-based applications and systems, such as MSOffice, DocX Tool, Label/Regulatory Intelligence platforms, eDMS, data analytics tool(s), etc., for completing daily tasks 

•Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality and others who contribute to RIM. 

• Demonstrates ability to apply knowledge in a regulated environment, and functions independently in decision making for routine issues, while completing labeling inquiries from cross-functional areas, often under tight timelines. 

•Provides SME support on labeling systems and processes. Troubleshoots errors and system performance issues related to the RIM systemGLS. Coordinates with Program Support and IT to identify and resolve GLS RIMsystem issues. 

•Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems. 

•Prepares routine communications for functional area and senior leadership as requested, including core labeling information dissemination.  

•Executes business processes for product information management within RIM system, labeling document reviews (format and content) and for US drug listings and CA XML-PM tasks. 

•May informally manage the work of other department members. Assists in training of new personnel and in the development of department processes/policies.