Senior Associate RA Global Label Operations
North Chicago, IL, United States Hybrid
$84,500–$162,000 a yearJobFig found this opening at its original source and checks that it remains available.
About the role
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.
What you'll bring
- Bachelor’s degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences, or Associate’s degree and 8 years related experience
- Required Experience: 3+ years in regulatory affairs, R&D or related area.
- Experience working in a complex global matrix environment with diverse team members.
- Strong communication skills, both oral and written, and strong attention to detail, with problem-solving skills
- Note: Higher education may compensate for years of experience
- Preferred Experience: Experience working with electronic regulatory submissions, software tools, and data standards, prior experience in a regulatory affairs strategy role preferred.