Senior Regulatory Affairs Associate - Labeling

September 30

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• Improve the world's health through clinical trials and regulatory consulting. • Contribute to the development of therapies for patients. • Collaborate with teams to manage labeling documentation and artwork approval processes.

Requirements

• 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.