Senior Regulatory Affairs Consultant – Labeling, European Expertise

Job Description: • Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets. • Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. • Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. • Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. • Act as operational expert for Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades. Requirements: • Bachelor’s Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. • Strong attention to detail • Solid understanding and interpretation of EU/US labeling regulatory requirements • Solid understanding of requirements for tracking of labeling updates • Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice • Ability to recognize and escalate issues Benefits: • Health insurance • Professional development opportunities • Flexible working arrangements • Paid time off Apply tot his job