Senior Regulatory Affairs Associate- Labeling
India, Remote 求人ID R0000024061 Category Regulatory / ConsultingAbout this Role
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
JOBS FOR YOU
There is no jobs to view
現在、閲覧できる保存されたポジションはありません。
このサイトで保存されたポジションを表示できるようにするために、クッキーの受け入れを有効にしてください。このページにアクセスすると、保存されたポジションを確認することができます。
More Than A Job
