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We are looking for a Senior Consultant Regulatory Affairs for Labelling. This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based). In this role you will partner with Label Strategist to:
1. Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
2. Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed.
3. Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
4. Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.
You will also:
5. Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
6. Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades.
7. Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
8. Support labeling inspection / audit readiness activities
Skills and Experience:
9. University Degree in a scientific degree
10. 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
11. Good working knowledge of key labeling regulations/guidance and past experience in label development
12. The ability to research and create comparator labeling documents
13. Electronic document management systems use and / or electronic submission experience
14. Solid understanding of requirements for tracking of labeling updates. Understanding of label development and submission processes preferred.
15. Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS). Ability to manage the review and approval of labeling in a document management system.
16. The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
17. Fluent in English written and spoken