Regulatory Labeling Specialist
17 hours ago
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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