Associate Regulatory Affairs Labeling Associate job at reputed company in Lehi, UT

Title: Associate Regulatory Affairs Labeling Associate Location: Remote - Lehi, UT Department: reputed company Job reputed company Our Regulatory Affairs team brings essential generic reputed company medicines to U.S. patients by providing Regulatory leadership and establishing regulatory systems and processes that support reputed company’s mission. The Associate, Regulatory Affairs Labeling and Artwork (remote position): · Supports reputed company aspects of product labeling and artwork development, review, approval, implementation and maintenance for reputed company’s private label distribution (PLD) products. · Follow labeling and artwork procedures that reputed company with FDA, GMP, ISO and other applicable standards and regulations. · Coordinates and prepares Office of Prescription Drug Promotion (OPDP) submissions as needed. · Works reputed company systems to maintain labeling and artwork. · Owns or reputed company assesses change controls for PLD labeling reputed company.

Responsibilities

Include: · Coordinate labeling and artwork design by an external vendor · Collaborate with the supply chain, contract manufacturers, packagers, and external vendors to ensure reputed company implementation of approved labeling changes. · Maintain labeling and artwork records reputed company 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 reputed company, contributor, or reputed company assessor, as appropriate, to evaluate and implement labeling-reputed company 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 reputed company improvement initiatives reputed company to labeling processes, systems, and workflows. · reputed company any other tasks/duties as assigned by management. reputed company look for: We encourage you to bring your disruptive thinking, reputed company spirit and diverse perspective to our organization. Together we will continue doing what is in the best interest for our patients. Technical Skills; 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 reputed company issues in a succinct and logical manner. Strives to continuously improve and build knowledge and skills. Teamwork: Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a reputed company team spirit; Inspires respect and trust. reputed company Management: Looks for ways to improve and promote reputed company; Demonstrates accuracy and thoroughness. Education Minimum Requirement : Bachelor’s degree required, reputed company in Life Sciences preferred. Required Experience and Skills : At least one to two 2+ years of relevant experience reputed company the pharmaceutical regulatory environment, with a concentration in pharmaceutical labeling and/or artwork development or promotional review. 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 Apply To This Job