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
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