Regulatory Labeling Associate

Company DescriptionKesin Pharma partners with healthcare providers across diverse care settings to deliver high-quality prescription and OTC medications focused on efficiency, compliance, and reliability. The company offers unit dose formats as well as bulk bottles and blister packaging that help streamline pharmacy workflows and optimize storage space. Its solutions are designed to meet the evolving operational needs of pharmacies and healthcare organizations. With vertically integrated operations and strong distribution partnerships, Kesin Pharma provides consistent product quality and dependable supply. A customer-first approach ensures that services and solutions are tailored to the specific needs of each pharmacy partner.If you are considering sending an application, make sure to hit the apply button below after reading through the entire description.Role DescriptionThe Regulatory Labeling Associate supports the creation, review, organization, and maintenance of pharmaceutical labeling components, including PI, MG, packaging artwork, and product documentation. This role requires strong technical accuracy, familiarity with FDA labeling formats, and the ability to manage multiple labeling projects independently. The Associate is expected to execute tasks with minimal oversight, maintain structured documentation, and proactively identify issues before they reach the Regulatory Labeling Manager. This position requires a reliable contributor who consistently delivers accurate, audit-ready work in a fast-paced, detail-driven environment.Key ResponsibilitiesTechnical Labeling ExecutionPerform detailed proofing of PI, MG, carton/dieline artwork, and supplier filesIndependently compare supplier PDFs, print proofs, and internal labeling documents using redlines and structured review checklistsValidate regulatory sections, formatting, symbols, NDC structure, dosage form statements, and required OTC/ANDA elementsPrepare complete artwork packets for internal review and external partnersSupport SPL review or preparation (if applicable), ensuring alignment with PI/MG contentDocumentation & Version ControlMaintain accurate version control across PI, MG, carton/dieline, and labeling change documentationEnsure all files follow established naming conventions and archiving rulesManage labeling trackers, change logs, and project timelines with minimal oversightIdentify missing documentation, inconsistencies, or supplier gaps and escalate proactivelyEnsure assigned labeling components are complete, accurate, and audit-ready at all timesRegulatory & Cross-Functional CoordinationCoordinate labeling updates driven by supplier changes, regulatory updates, project changes, or artwork revisionsCommunicate clearly with QA, Supply Chain, Production, and external partners to ensure timely executionPrepare structured documentation for change control, regulatory submissions, and internal approvalsQuality & ComplianceFollow SOPs, WIs, and labeling workflows with consistencyEnsure all labeling components meet FDA formatting, content, and structural requirementsFlag potential compliance risks early and propose corrective actionsAdditional tasks as assigned within the scope of labeling and regulatory documentationCore CompetenciesAbility to work independently and deliver accurate work without repeated correctionStrong analytical skills xhyhwjd and ability to interpret regulatory requirementsHigh personal accountability and consistency in meeting deadlinesClear, professional communication skillsCommitment to maintaining organized, audit-ready documentationDemonstrates ownership of assigned labeling components and drives tasks to completion without repeated follow-upRequired Qualifications2–4 years of experience in pharmaceutical labeling, document control, regulatory affairs, or similar FDA-regulated environmentStrong proficiency with Adobe Acrobat, redline tools, and PDF comparisonExperience reviewing PI/MG formats, OTC Drug Facts, or SPLAbility to manage multiple projects independently and maintain accuracy under deadlinesStrong organizational skills and attention to detailClear, professional communication skillsPreferred QualificationsExperience with artwork systems, labeling software (e.g., CodeSoft), or print-ready file reviewFamiliarity with ANDA/OTC labeling requirementsExperience supporting change control or regulatory submissions