Hiring: Regulatory Labeling Associate Company: Kesin Pharma Location: Oldsmar, FL Job Posted Time: 2026-09-10 10:39:51 About the job Experience: •4 years of experience in pharmaceutical labeling, document control, regulatory affairs, or similar FDA-regulated environment Required Skills: •Perform detailed proofing of PI, MG, carton/dieline artwork, and supplier files •Independently compare supplier PDFs, print proofs, and internal labeling documents using redlines and structured review checklists •Validate regulatory sections, formatting, symbols, NDC structure, dosage form statements, and required OTC/ANDA elements •Prepare complete artwork packets for internal review and external partners •Support SPL review or preparation (if applicable), ensuring alignment with PI/MG content •Maintain accurate version control across PI, MG, carton/dieline, and labeling change documentation •Ensure all files follow established naming conventions and archiving rules •Manage labeling trackers, change logs, and project timelines with minimal oversight Qualifications: •2–4 years of experience in pharmaceutical labeling, document control, regulatory affairs, or similar FDA-regulated environment •Strong proficiency with Adobe Acrobat, redline tools, and PDF comparison •Demonstrated capacity to manage multiple projects independently and maintain accuracy under deadlines •Strong organizational skills and attention to detail •Operational familiarity with ANDA/OTC labeling requirements Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!