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 issuesBenefits:• Health insurance• Professional development opportunities• Flexible working arrangements• Paid time off Apply tot his job