Associate Regulatory Affairs Labeling Associate

Responsibilities

• Coordinate labeling and artwork design by an external vendor
• Collaborate with the 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, as appropriate, 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

Requirements

• Proven experience in critically reviewing documents for consistency and accuracy
• Excellent proofreading/editing skills are required
• Strong organizational skills
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner
• Strives to continuously improve and build knowledge and skills

Qualifications

• Minimum Requirement: Bachelor’s degree required, focus in Life Sciences preferred
• At least one to two 2+ years of relevant experience within the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or promotional review