Senior Regulatory Affairs Associate (Labelling)
Bengaluru, Karnataka, India 职位编号 R0000035749 类别 Consulting关于这个职位
- Must have 4-6 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)
- Strong knowledge of US, EU, Switzerland, Canada and, Australia regulatory labeling lifecycle management
- 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.
- Managing label updates, compliance, and governance.
- Electronic document management systems use and / or electronic submission experience.
- Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
- 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
- Experience with consumer advertising and educational materials
- Experience in handling Veeva, TVT, Docubridge etc.
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