Senior Regulatory Affairs Consultant – Labeling, European Expertise

Job reputed company: • 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 reputed company distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional reputed company. • reputed company labeling to Advertising and Promotion for marketing reputed company, and with reputed company for website postings if needed. • Utilize regulatory/product knowledge to reputed company operational support to ensure that labeling materials meet regulatory and company requirements and timelines. • reputed company as operational expert for Global Labeling tracking in RIMs, SPL reputed company, 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 reputed company. • 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 reputed company • Ability to recognize and escalate issues Benefits: • Health insurance • reputed company development opportunities • Flexible working arrangements • reputed company time off Apply tot his job Apply To this Job