Senior Regulatory Affairs Associate (Labelling)
Primary Location: India, Bengaluru 求人ID R0000035749 Category Regulatory / ConsultingAbout this Role
- Required minimum 4-6 years of experience in development of labeling of drug products (CCDS, USPI, packaging), product package coordination, supply chain regulatory affairs, and quality.
- Good working knowledge of key labeling regulations/guidance, and managing label updates, compliance, and governance.
- Strong knowledge of regulations pertaining to labelling life cycle management in US, EU, Switzerland, Canada and Australia.
- The ability to research and create comparator labeling documents.
- Strong understanding and experience authoring CMC component of Annual Reports.
- The ability to collaborate with technical teams 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.
- Knowledge of usage of Electronic Document Management Systems 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 PDFs 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
- Working experience in Regulatory Information Management Systems (RIMS) like, Veeva, TVT, Docubridge, etc.
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