Actalent
Arlington Heights, IL, USA
Job Title: Regulatory Labeling Associate Job Description As a Regulatory Labeling Associate, you will be responsible for supporting the Quality Assurance and Regulatory departments by managing product labeling tasks and assisting with regulatory submissions. This position offers the opportunity to grow within the organization and contribute to new labeling initiatives following FDA guidelines. Responsibilities Review and manage product labeling. Prepare and submit Structured Product Labeling (SPL) files. Provide support for executing Change Controls. Project manage new labeling initiatives for both new and existing products. Conduct research using FDA and global regulatory websites for submissions. Assist in preparing documentation for regulatory submissions. Support client inspections and audits. Perform data entry and documentation using Microsoft Excel and internal databases. Assist with FDA and client audit...