Labeling Specialist/Manager
1 month ago
Job Summary: The Regulatory Labeling Specialist/Manager is responsible for managing and overseeing the development, and review of product labels and packaging to ensure compliance with FDA requirements. This role involves working closely with cross-functional teams to support submission, review and product launches while maintaining ongoing compliance throughout the product lifecycle in alignment with Long Grove style guidelines.
Department: Regulatory Affairs
Reports To: Regulatory Affairs Manager / Director /Vice President
Key Responsibilities:
Labeling Compliance: Develop, review, and approve product labels and packaging materials to ensure compliance with FDA, Long Grove style guide.
Regulatory Knowledge: Stay current with changes in regulations, guidelines, and industry best practices related to labeling and packaging. Interpret and apply regulatory requirements to ensure product labels are accurate and compliant.
Cross-Functional Collaboration: Work closely with Regulatory Affairs, Quality Assurance, Marketing, and Product Development teams to gather information and ensure that all labels aligned with product specifications.
Labeling Documentation: Prepare and maintain comprehensive labeling documentation, including label copies, regulatory submissions, and compliance records.
· Manage the graphic designer process between Leader Board and LGP
· Generation of side-by-side labels between the proposed label/last sequence and RLD throughout the review process
Day to Day Activities: Keep abreast of regulations and guidelines, generate narratives for submission graphics generation, monitor Drugs@FDA website and revise labels to align with RLD updates.
Applicable Guidelines:
Complying with Labeling for Human Prescription
Complying with 21 CFR 201.57
Complying with Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry
Label Change Management: Manage labeling changes and updates, including coordinating with relevant departments to implement changes, conduct impact assessments, and ensure timely updates to labels and packaging.
Project Management: Manager labeling projects from inception through implementation, ensuring that deadlines are met and that the labeling meets 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 a plus.
Experience: 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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