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Regulatory Inspection Readiness Lead

Job in Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for: RXinsider LTD.
Full Time position
Listed on 2026-08-12
Job specializations:
  • Quality Assurance - QA/QC
  • Government
Salary/Wage Range or Industry Benchmark: 131000 - 209000 USD Yearly USD 131000.00 209000.00 YEAR
Job Description & How to Apply Below

Moderna, based in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory authority inspections (FDA, EMA) across R&D. You will build stakeholder relationships, prepare for inspections, respond to observations, and track CAPAs to closure, contributing to an inspection-ready culture.

You will lead trainings, mock inspections, and development of inspection plans, while partnering with cross-functional teams to ensure compliance and timely regulatory responses in a

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