Regulatory Affairs and Compliance Coordinator

Recruiting Solutions; South Carolina; On-site; USD 42,000 - 54,000; Full time

Job summary

Recruiting Solutions is seeking a regulatory labeling professional to create and revise product label verbiage for dietary supplements, foods and OTCs. The role emphasizes compliance with CFR/DSHEA/FTC and cGMP, plus coordination with artwork vendors.

The candidate will review artwork for accuracy, support cross-functional teams, and assist senior regulatory staff in various duties, ensuring timely, compliant packaging materials.

Qualifications

• Two year degree.
• 1+ years’ experience in a manufacturing environment. (Regulatory Affairs, Quality, or R&D experience preferred)
• Well organized, detail oriented, and a strong desire for accuracy
• Highly developed written and verbal skills
• Excellent copy-editing and proof-reading skills
• Ability to perform mathematical calculations for verifying product potencies.
• Strong computer skills to include Microsoft Word and Excel. Experience with Oracle, SharePoint, MAPICS, Adobe Creative Suite or any Document Control System a plus

Responsibilities

• Create verbiage for product labels (dietary supplement, food, and OTC) and revise artwork.
• Maintain knowledge of industry regulations (CFR/DSHEA/FTC) domestic and foreign
• Prepare label scripts for artwork initiation complying with regulations
• Review artwork components for accuracy and compliance with regulations and style guides
• Coordinate artwork proofs with print vendors for timely delivery
• Process print artwork and provide approval for packaging use
• Support Customers, Marketing, Product Development, R&D, Regulatory, Customer Service and QC
• Assist Sr. Mgr. Regulatory Affairs & Label Compliance and Sr. Regulatory Affairs Supervisor as assigned

Skills

Detail oriented

Written & verbal communication

Copy-editing

Mathematical calculations

Manufacturing experience

Education

Two year degree

Tools

Word

Excel

Oracle

SharePoint

MAPICS

Adobe Creative Suite

Job description

Responsible for creating verbiage for new product labels (dietary supplement, food, and OTC) and revising existing product artwork, in a timely manner, ensuring accuracy and compliance with all industry regulations, both domestic and foreign, and customer requirements.

Responsibilities:

• Maintain an accurate and current knowledge of pertinent industry regulations: Food and Dietary Supplement labeling regulations (CFR/DSHEA/FTC), including domestic and foreign regulations
• Have a good understanding of current good manufacturing practices (cGMP) regulations
• Prepare label scripts for artwork initiation that complies with all, local, state and federal food and dietary labeling regulations
• Review all product artwork components in a timely manner, for accuracy and ensuring full compliance with industry regulations, customer requirements, and style guides
• Coordinate artwork proofs with print vendors, ensuring accurate and timely delivery of packaging materials
• Process in print artwork and provide approval for use in packaging
• Provide active support to the Customers, Marketing, Product Development, R&D, Regulatory, Customer Service, QC, and related departments
• Assist the Sr. Mgr. Regulatory Affairs & Label Compliance and Sr. Regulatory Affairs Supervisor in other duties as assigned

Qualifications:

• Two year degree.
• 1+ years’ experience in a manufacturing environment. (Regulatory Affairs, Quality, or R&D experience preferred)
• Well organized, detail oriented, and a strong desire for accuracy
• Highly developed written and verbal skills
• Excellent copy-editing and proof-reading skills
• Ability to perform mathematical calculations for verifying product potencies.
• Strong computer skills to include Microsoft Word and Excel. Experience with Oracle, SharePoint, MAPICS, Adobe Creative Suite or any Document Control System a plus