Associate Regulatory Affairs Labeling Associate
RemoteUnited States
Job Summary
Coordinate labeling and artwork design with external vendors and collaborate with supply chain partners to ensure timely implementation of approved changes. Review labeling components and artwork for accuracy, consistency, and compliance with FDA, GMP, and ISO standards while maintaining records within electronic systems. Own or impact assess change controls for private label distribution products and support Office of Prescription Drug Promotion submissions. Maintain FDA drug listings and associated regulatory records, driving continuous improvement in labeling workflows. This remote role supports Civica's mission to bring essential generic medicines to U.S. patients through robust regulatory systems.
Required Qualifications
- Bachelor's degree
- Focus in Life Sciences preferred
- At least one to two 2+ years of relevant experience within the pharmaceutical regulatory environment
- Concentration in pharmaceutical labeling and/or artwork development
- Promotional review
- Proven experience in critically reviewing documents for consistency and accuracy
- Excellent proofreading/editing skills
- Strong organizational skills
- Demonstrated superior oral and written communication skills
- Ability to communicate complex issues in a succinct and logical manner
- Balances team and individual responsibilities
- Exhibits objectivity and openness to others' views
- Gives and welcomes feedback
- Contributes to building a positive team spirit
- Inspires respect and trust
- Looks for ways to improve and promote quality
- Demonstrates accuracy and thoroughness
- Minimal travel (0-5%)
- Work in a typical office environment
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