[Remote] Senior Regulatory Affairs Consultant - Labeling (US and Global Strategy Expertise)

Note: The job is a remote job and is open to candidates in USA. Parexel is a leading global biopharmaceutical company seeking a Senior Regulatory Affairs Consultant specializing in labeling. In this role, you will provide strategic direction and oversight for global labeling, ensuring compliance and continuous improvement in labeling processes while collaborating with various teams to support regulatory and safety objectives.

Responsibilities

• Serve as the global labelling lead for multiple products, providing strategic direction and oversight.
• Lead the development and maintenance of Company Core Data Sheets (CCDS), local labels, and associated labelling components.
• Chair the Cross-Functional Labelling Team (XLT), facilitating the development of label updates and enabling senior management review and approval.
• Ensure regional labelling compliance with CCDS standards.
• Evaluate health authority comments for labelling implications and lead the development of appropriate responses.
• Participate in Safety Management Team (SMT) and Global Regulatory Team (GRT) meetings to provide expert input on labelling matters.
• Monitor emerging safety signals and assess potential impact on labelling.
• Provide strategic insight and guidance on labelling topics to support regulatory and safety objectives.
• 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.
• 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 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
• 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
• Strong attention to detail
• 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
• 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, and be comfortable working with multifunctional teams
• 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
• Understanding of label development and submission processes preferred Company Overview
• Parexel is among the world’s largest

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