Senior Regulatory Affairs Associate- Labeling

2 months ago


Chandigarh, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

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

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