Senior Associate, Regulatory Lifecycle Management

at AbbVie US LLC in North Chicago, Illinois, United States

Job Description

Senior Associate, Regulatory Lifecycle Management, AbbVie Inc., North Chicago, IL. Responsible for monitoring the activity in Cosmos (the Regulatory Information Management system) for assigned portfolio products and ensuring the completeness and accuracy of RIM data in the Cosmos system. Work with submission teams and provide appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in Cosmos as described in functional area procedures. Work within an electronic Regulatory Information Management (RIM) system (e.g. Cara Life Science Platform) to create product, application and authorization data for pharmaceutical, device and cosmetic products in alignment with defined data standards. Determine system properties appropriate for the classification type/submission type of object desired by the business in Cosmos. Utilize knowledge of regulatory submissions process. Build submission and correspondence history within the RIM system for complex regulatory applications. Elevate non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations. Responsible for educating internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality and others who contribute to RIM. Extract data from the RIM system to address common regulatory reporting needs (e.g. Global Marketing Authorization report). Review complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options. Prepare routine communications for functional area and senior leadership as requested. Execute business processes for activity type and product information management within Cosmos. 100% telecommunicating permitted. Must possess a Bachelor’s degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, or a closely related field of study with at least 2 years of related experience in the following: (i) experience working within an electronic Regulatory Information Management (RIM) system (e.g. Cara Life Science Platform) to create product, application and authorization data for pharmaceutical, device and cosmetic products in alignment with defined data standards; (ii) knowledge of regulatory submissions process; (iii) experience building submission and correspondence history within the RIM system for complex regulatory applications; & (iv) extracting data from the RIM system to address common regulatory reporting needs (e.g. Global Marketing Authorization report). 100% Telecommuting permitted. Apply online at https://careers.abbvie.com/en & reference REF23808D.