Regulatory Labeling Coordinator

1 week ago

Chicago, Illinois, United States Trinite Consulting Group Full time
Job Overview

Position Summary: The Regulatory Labeling Coordinator plays a crucial role in overseeing the creation and evaluation of product labels and packaging to ensure adherence to FDA regulations. This position requires collaboration with various teams to facilitate submissions, reviews, and product launches while ensuring continuous compliance throughout the product lifecycle, in accordance with company style guidelines.

Department: Regulatory Affairs

Reports To: Regulatory Affairs Manager / Director / Vice President

Key Responsibilities:

  • Labeling Compliance: Develop, assess, and authorize product labels and packaging materials to ensure they meet FDA standards and company style guidelines.
  • Regulatory Knowledge: Remain informed about updates in regulations, guidelines, and industry best practices related to labeling and packaging. Analyze and apply regulatory requirements to guarantee the accuracy and compliance of product labels.
  • Cross-Functional Collaboration: Collaborate closely with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to collect necessary information and ensure that all labels align with product specifications.
  • Labeling Documentation: Create and maintain thorough labeling documentation, including label drafts, regulatory submissions, and compliance records.
  • Graphic Design Management: Oversee the graphic design process between departments to ensure alignment with labeling requirements.
  • Label Comparison: Generate side-by-side comparisons of proposed labels and reference labels throughout the review process.
  • Day-to-Day Activities: Stay updated on regulations and guidelines, produce narratives for submission graphics, monitor updates, and revise labels to align with reference label changes.
  • Label Change Management: Manage updates and modifications to labels, coordinating with relevant departments to implement changes, conduct impact assessments, and ensure timely updates.
  • Project Management: Lead labeling projects from initiation to execution, ensuring deadlines are met and that labeling complies with all regulatory and quality standards.

Qualifications:

  • Education: Bachelor's degree in Life Sciences, Regulatory Affairs, Chemistry, or a related field. Advanced degrees or certifications in Regulatory Affairs (e.g., RAC) are advantageous.
  • Experience: A minimum of 3-5 years of experience in regulatory labeling or a related field within the pharmaceutical, biotechnology, medical device, or consumer goods sectors.

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