Senior Regulatory Affairs Associate

Regulatory Affairs Labeling

• Bachelor’s Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
• Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
• The ability to research and create comparator labeling documents.
• Strong understanding and past experience creating annual reports
• The ability to collaborate with Tech Ops for artwork implementation
• Proficiency in SPL (all aspects, types and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
• Electronic document management systems use and / or electronic submission experience.
• Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.