Regulatory Associate/Labeling Coordinator

3 weeks ago


Durham, United States Accuro Full time

Business Title: Regulatory Associate/Labeling Coordinator

Location: Durham, NC

Job Type: 12+ Months contract


***HYBRID POSITION***


Job Responsibilities

  • Responsible for the production (authoring or assisting the authors), in terms of quality and regulatory acceptability of manuscripts for new/revised prescribing information for products marketed in the US
  • Identifies and resolves problems in a proactive manner
  • Suggests creative approaches to capture labeling concepts in a succinct manner
  • Ensures appropriate consistency in labeling documents across products for assigned area of responsibility.
  • Works with Labeling Strategy staff to ensure compliance with US Labeling processes
  • Must be able to effectively articulate FDA and CLIENT requirements for labeling documents to CLIENT matrix teams, champion change, and recommend unique solutions, as needed
  • Ensures all labeling regulatory requirements associated with assigned products are met
  • Works with Matrix Team to resolve any labeling issues in a proactive manner
  • Ensures accurate version control of multiple labeling submissions and components
  • Develops FDA-compliant XML labeling documents for submission in accordance with CLIENT or FDA timelines
  • Works with internal Drug Listing experts to coordinate Drug Listing submissions via XML labeling
  • Produces all required versions of prescribing information documents for submission purposes and ensures all submission requirements are met for these documents
  • Completes all assigned tasks to project deadlines
  • Is able to manage own time at the task level and works on multiple projects in parallel
  • Provides summaries of Labeling updates as needed for NDA or BLA Annual Reports
  • The major outputs of this position are:
  • Provision of Regulatory advice regarding prescribing information requirements to a range of development projects and more broadly across the Global Regulatory Affairs and CLIENT Matrix Teams
  • Ensuring prescribing information for prescription products in the US meet all regulatory requirements
  • o Production of FDA-compliant XML labeling documents.
  • o Ensuring proper version control of US prescribing information.



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