Regulatory Associate/Labeling Coordinator
3 weeks ago
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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