Regulatory Affairs Consultant / Senior Consultant - Labeling - Remote

Company: PAREXEL
Location: Smyrna
Posted on: June 19, 2022

Job Description:

INCREDIBLE HOME-BASED OPPORTUNITY DEDICATED TO ONE CLIENT If you passionate about labeling, have a passion for Regulatory Affairs, and are looking for an opportunity to work with an amazing team, then Parexel's Consulting has the perfect opportunity for you Parexel---s Consulting Team is expanding, and we are seeking a Senior/Consultant, Regulatory Labeling to partner with our global client on US related labeling activities As a Senior/Consultant, Regulatory Labeling, 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 Qualifications Education 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 Knowledge and Skills Strong attention to detail Solid understanding and interpretation of US labeling regulatory requirements preferred 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. Ability to recognize and escalate issues Strong written and oral communication and organizational skills Ability to generate and initiate problem solving innovative solutions 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 This is a home-based role; however, in the future 15% domestic / international travel may be required to client offices coupled with flexibility to travel to Parexel's offices for team/client meetings Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Smyrna , Regulatory Affairs Consultant / Senior Consultant - Labeling - Remote, Professions , Smyrna, Georgia