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Regulatory Affairs Consultant

3 miesięcy temu

Warszawa, Polska Parexel Pełny etat

When our values align, there's no limit to what we can achieve.
 

We are looking for a Consultant Regulatory Affairs for Labeling . 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 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 (USPI, Med Guide, SmPC, PIL, Canadian Product Monograph, Instructions for Use) 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, SPL generation, 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: Bachelor’s Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Exceptional candidates with 3+ years of labeling related experience may also be considered 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 past 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 Solid understanding and interpretation of US labeling regulatory requirementspreferred Solid understanding of requirements for tracking of labeling updates Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency in MS Office suite; Willing to learn additional applications Understanding of label development and submission processes preferred. 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