Senior Analyst, Regulatory Affairs Information Management

Role Summary

The Senior Analyst, Regulatory Affairs Information Management is 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. Works with submission teams and provides appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in Cosmos as described in functional area procedures.

Responsibilities

• Determines system properties appropriate for the classification type/submission type of object desired by the business in Cosmos
• Elevates non-compliant records appropriately to the business user or regulatory admin for resolution using AbbVie change management expectations
• Demonstrates ability to apply knowledge in a regulated environment
• 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
• Functions independently in decision making for routine issues
• In conjunction with manager, reviews complex issues and problem resolution successes and setbacks to assist in future problem-solving applications/options
• 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
• Executes business processes for activity type and product information management within Cosmos

Qualifications

• Required Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences
• Required Experience: 4+ years in regulatory affairs, R&D or related area
• Experience working in a complex global matrix environment with diverse team members. Good communication, both oral and written
• Preferred Experience: Experience working with electronic regulatory submissions and data standards, prior experience in a regulatory affairs strategy role preferred

Additional Requirements

• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required