About this opportunity
Kesin Pharma lists this Regulatory Labeling Associate opportunity in oldsmar, Florida. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Company Description
Kesin 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.
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Role Description
The 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 Responsibilities
Technical Labeling Execution
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
Documentation & Version Control
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
Identify missing documentation, inconsistencies, or supplier gaps and escalate proactively
Ensure assigned labeling components are complete, accurate, and audit‑ready at all times
Regulatory & Cross-Functional Coordination
Coordinate labeling updates driven by supplier changes, regulatory updates, project changes, or artwork revisions
Communicate clearly with QA, Supply Chain, Production, and external partners to ensure timely execution
Prepare structured documentation for change control, regulatory submissions, and internal approvals
Quality & Compliance
Follow SOPs, WIs, and labeling workflows with consistency
Ensure all labeling components meet FDA formatting, content, and structural requirements
Flag potential compliance risks early and propose corrective actions
Additional tasks as assigned within the scope of labeling and regulatory documentation
Core Competencies
Ability to work independently and deliver accurate work without repeated correction
Strong analytical skills xhqgsiq and ability to interpret regulatory requirements
High personal accountability and consistency in meeting deadlines
Clear, professional communication skills
Commitment to maintaining organized, audit‑ready documentation
Demonstrates ownership of assigned labeling components and drives tasks to completion without repeated follow‑up
Required 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
Experience reviewing PI/MG formats, OTC Drug Facts, or SPL
Ability to manage multiple projects independently and maintain accuracy under deadlines
Strong organizational skills and attention to detail
Clear, professional communication skills
Preferred Qualifications
Experience with artwork systems, labeling software (e.g., CodeSoft), or print-ready file review
Familiarity with ANDA/OTC labeling requirements
Experience supporting change control or regulatory submissions
Worksite address
oldsmar, FL, 34677, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.