Regulatory Labeling Associate

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.

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 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