Regulatory Labeling Specialist

17 hours ago


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

The Regulatory Labeling Specialist/Manager is responsible for ensuring compliance with FDA requirements for product labels and packaging. This role involves working closely with cross-functional teams to support submission, review, and product launches while maintaining ongoing compliance throughout the product lifecycle.

Key Responsibilities:

  • Develop, review, and approve product labels and packaging materials to ensure compliance with FDA and Long Grove style guide.
  • Stay current with changes in regulations, guidelines, and industry best practices related to labeling and packaging.
  • Work closely with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to gather information and ensure that all labels are aligned with product specifications.
  • Prepare and maintain comprehensive labeling documentation, including label copies, regulatory submissions, and compliance records.

Qualifications:

  • Bachelor's degree in Life Sciences, Regulatory Affairs, Chemistry, or a related field.
  • Minimum of 3-5 years of experience in regulatory labeling or a related field within the pharmaceutical, biotechnology, medical device, or consumer goods industry.


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