Senior Regulatory Affairs Consultant (Label Strategist)

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:

• Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets.
• 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.
• Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control.
• Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines.

You will also:

• Be responsible for executing 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.
• Act as operational expert for the Global Labeling tracking in RIMs, ensure development and maintenance of templates, collaboration features and system upgrades.
• Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation.
• Support labeling inspection/audit readiness activities.

Skills and Experience:

• University Degree in a scientific degree.
• 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.
• The ability to research and create comparator labeling documents.
• Electronic document management systems use and/or electronic submission experience.
• Solid understanding of requirements for tracking of labeling updates.
• Understanding of label development and submission processes preferred.
• 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.
• 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.
• Fluent in English written and spoken.