Associate Regulatory Affairs Labeling Associate at Civica Rx
United States
<p><strong></strong><strong>Job Description</strong></p><p>Our Regulatory Affairs team brings essential generic quality medicines to U.S. patients by providing Regulatory leadership and establishing regulatory systems and processes that support Civica’s mission.</p><p>The Associate, Regulatory Affairs Labeling and Artwork (remote position):</p><p>· Supports all aspects of product labeling and artwork development, review, approval, implementation and maintenance for Civica’s private label distribution (PLD) products.</p><p>· Follow labeling and artwork procedures that comply with FDA, GMP, ISO and other applicable standards and regulations.</p><p>· Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions as needed.</p><p>· Works within systems to maintain labeling and artwork.</p><p>· Owns or impact assesses change controls for PLD labeling impact.</p><p><strong>Responsibilities Include:</strong><br><br>· Coordinate labeling and artwork design by an external vendor</p><p>· Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure timely implementation of approved labeling changes.</p><p>· Maintain labeling and artwork records within applicable electronic systems and document repositories.</p><p>· Support preparation and submission of Office of Prescription Drug Promotion (OPDP) materials, as needed.</p><p>· Maintain FDA drug listings information and associated regulatory records.</p><p>· Participate in change control activities as a change owner, contributor, or impact assessor, as appropriate, to evaluate and implement labeling-related changes.</p><p>· Review labeling components and artwork for accuracy, consistency, completeness, and compliance with approved regulatory content.</p><p>· Ensure labeling information included in regulatory submissions is complete, accurate, and consistent.</p><p>· Support continuous improvement initiatives related to labeling processes, systems, and workflows.</p><p>· Perform any other tasks/duties as assigned by management.</p><p><strong>What we look for:</strong></p><p>We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest for our patients.</p><p><strong>Technical Skills;</strong></p><p>Proven experience in critically reviewing documents for consistency and accuracy. Excellent proofreading/editing skills are required.</p><p>Strong organizational skills.</p><p>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.</p><p><strong>Teamwork:</strong></p><p>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.</p><p><strong>Quality Management:</strong></p><p>Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.</p><p><strong>Education Minimum Requirement :</strong></p><p>Bachelor’s degree required, focus in Life Sciences preferred.</p><p><strong>Required Experience and Skills :</strong></p><p>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.</p><p>Physical demands of the position include only those required for work in a typical office environment. Minimal travel (0-5%) may be necessary in the execution of the listed duties</p>
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