Regulatory Labeling Manager Jobs in East Rutherford, NJ

CCL Label is part of CCL Industries, a global organization with over 26,000 employees and more than 213 production facilities in 42 countries, supported by corporate offices in Toronto, Canada, and Framingham, Massachusetts. CCL Label is the world’s largest converter of pressure-sensitive and extruded film materials, serving major brands in consumer packaging, agriculture, healthcare, automotive, and consumer durables.

CCL Label’s mission is to be the global supply chain leader for innovative label solutions across consumer packaging, consumer durables, and healthcare sectors. Its diverse market presence includes food and dairy, beauty and personal care, home care and laundry, specialty chemicals, beverage, wine and spirits, healthcare, promotions, tubes, automotive, durables, and security applications.

Role Description

The Clinical Labeling Specialist – Clinical Labels & Booklet Production is a full-time, on-site role based in Garden City, NY. This position is responsible for coordinating and producing clinical labels and booklets, ensuring accuracy, regulatory compliance, and alignment with client specifications. Day-to-day tasks include reviewing clinical protocols and study documentation, translating requirements into clear labeling instructions, and preparing artwork and print-ready files for production. The specialist collaborates with internal production, quality, and regulatory teams, as well as client contacts, to resolve labeling questions, manage timelines, and support issue resolution. Additional responsibilities include maintaining documentation, supporting process improvements, and ensuring that all clinical labeling materials are produced on time and to the required quality standards.

Key Responsibilities

• Participate in pre-production reviews with the Project Leader.
• Select and allocate appropriate label stock for production jobs.
• Prepare production rooms and workstations for area clearance.
• Print labels according to customer specifications and project requirements.
• Monitor printing operations to identify and address quality issues, defects, or production concerns.
• Perform reprint and integration activities for replacement labels as needed.
• Prepare packaging labels and supporting materials.
• Accurately document production activities and maintain required records throughout each run.
• Review production documentation for completeness and accuracy before submitting to Quality Assurance (QA) for review and release.
• Support shipping and fulfillment activities to meet customer requirements.
• Assist with additional operational tasks as needed to support day-to-day business operations.
• Knowledge of GCP, GMP, or related regulatory standards and prior experience with clinical trial materials is beneficial.

Qualifications & Requirements

• High School Diploma or equivalent required.
• Minimum 1 year of experience in clinical label production and clinical trial booklet production.
• Experience working in a regulated manufacturing, pharmaceutical, biopharmaceutical, clinical research, or healthcare environment preferred.
• Working knowledge of current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Strong proofreading skills with the ability to review printed materials, labels, and production documentation for accuracy.
• Ability to follow detailed verbal and written instructions and adhere to established procedures.
• Strong attention to detail with a commitment to accuracy and quality.
• Ability to maintain detailed production records and documentation in accordance with quality and compliance requirements.
• Basic mathematical, grammatical, and computer skills.
• Effective verbal and written communication skills.
• Ability to identify and resolve production issues while maintaining quality standards.
• Ability to work independently and collaboratively in a fast-paced production environment.
• Demonstrated ability to handle confidential customer and clinical trial information with discretion and professionalism.

Employment Type: Full-Time

Location: Garden City, NY

Work Arrangement: On-site

Hourly Rate: $24.64 - $25.64

Work Environment

CCL Clinical Systems is committed to providing a clean, safe, and professional work environment for all employees. This position requires working in a production setting where attention to detail, quality, and compliance are essential.