Senior Regulatory Affairs Associate- Labeling

Job Description-

• Must have  4+ 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 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.
• Must have handled CCDS related submission / safety variations / PSUR / xEVMPD / Label and artwork updates.
• Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
• Monitor, manage and control artwork changes.
• To manage and maintain the Artwork Trackers & Systems.
• To ensure artwork PDF’s are maintained and latest versions are readily available.
• Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved