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Regulatory Affairs Manager II

Oakbrook, MA 60523

Posted: 04/08/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 603392 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $58-63/hr
  • Performs eCTD submission management across the product portfolio to global Health Authorities for both major submissions and lifecycle management.
  • The Global Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products.
  • Oversee outsourced publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products.
  • Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders.
  • Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
  • Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality. Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.
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