Associate Regulatory Affairs Labeling Associate

Location: Remote within the United States; address listed in Petersburg, Virginia. Minimal travel of 0–5% may be required.

Company

A pharmaceutical organization focused on bringing essential generic quality medicines to U.S. patients through regulatory leadership and robust regulatory systems.

What you will do

• Support product labeling and artwork development, review, approval, implementation, and maintenance for private-label distribution products.
• Coordinate labeling and artwork design with external vendors and collaborate with supply chain, contract manufacturers, and packagers.
• Maintain labeling, artwork, FDA drug listing, and regulatory records in electronic systems and document repositories.
• Prepare and submit Office of Prescription Drug Promotion materials as needed.
• Own or assess change controls affecting labeling and participate in implementing labeling-related changes.
• Support continuous improvement of labeling processes, systems, and workflows.

Requirements

• Bachelor’s degree required; a focus in life sciences is preferred.
• At least 2 years of relevant experience in a pharmaceutical regulatory environment, particularly pharmaceutical labeling, artwork development, or promotional review.
• Strong document review, proofreading, and editing skills.
• Strong organizational skills and excellent written and oral communication skills.
• Ability to communicate complex issues clearly and logically in multicultural settings.
• Must work remotely from the United States; minimal travel of 0–5% may be required.

Culture & Benefits

• Collaborative environment emphasizing diverse perspectives and constructive feedback.
• Focus on accuracy, thoroughness, quality management, and continuous improvement.
• Remote work arrangement with only typical office-environment physical demands.
• Opportunities to build regulatory knowledge and professional skills.