Labeling Specialist/Manager - Bridge Technologies and Solutions

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.