Prepare, review, approve and manage labeling for pharmaceutical products for FDA submission in accordance with FDA regulations.
• Responsible for the creation of pharmaceutical labeling drafts for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Company requirements.
• Responsible for the creation of labeling in SPL and PLR format.
• Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.
• Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA.
• Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements.
• Responsible for maintenance of all labeling files in accordance with internal procedures
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Ability to work under tight deadline pressure and handle multiple projects.
• Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required.
• Must possess excellent communication and organizational skills, be a team player and have a meticulous eye for details.
5-8 Years Pharmaceutical Labeling Experience
SPL, Word, Excel, PowerPoint