Associate Regulatory Affairs Labeling Associate

About the role

The Associate, Regulatory Affairs Labeling And Artwork supports all aspects of product labeling and artwork development, review, approval, implementation, and maintenance for Civica’s private label distribution (PLD) products. This role ensures compliance with FDA, GMP, ISO, and other applicable standards and regulations, and coordinates Office of Prescription Drug Promotion (OPDP) submissions as needed.

Responsibilities

• Coordinate labeling and artwork design by an external vendor.
• Collaborate with supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes.
• Maintain labeling and artwork records within applicable electronic systems and document repositories.
• Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed.
• Maintain FDA drug listings information and associated regulatory records.
• Participate in change control activities as a change owner, contributor, or impact assessor to evaluate and implement labeling-related changes.
• Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content.
• Ensure labeling information included in regulatory submissions is complete, accurate, and consistent.
• Support continuous improvement initiatives related to labeling processes, systems, and workflows.
• Perform any other tasks/duties as assigned by management.

Requirements

• Bachelor’s degree required; focus in Life Sciences preferred.
• At least 2+ years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or 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 in multicultural settings and ability to communicate complex issues succinctly.
• Strives to continuously improve and build knowledge and skills.

Skills

• 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.

Schedule

Minimal travel (0-5%) may be necessary in the execution of the listed duties.

Physical Demands

Only those required for work in a typical office environment.