Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls Job at GE HealthCare, Remote

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  • GE HealthCare
  • Remote

Job Description

Senior Regulatory Affairs Manager responsible for Chemistry Manufacturing and Controls (CMC) regulatory strategy and quality dossier development for pharmaceutical diagnostic products throughout their lifecycle. This role provides strategic CMC input to support both development projects and marketed products at GE HealthCare.

Responsibilities

  • Develop and maintain quality sections of product dossiers (Module 2.3 and Module 3) throughout product lifecycle
  • Provide CMC regulatory strategies and input for assigned development projects and marketed products
  • Build submission strategy documents defining variation types, required data, and submission packages
  • Review, write, and edit CMC submission documents and dossier sections for regulatory submissions
  • Collaborate with global and regional regulatory affairs teams to address regulatory authority questions

Requirements

  • Bachelor's degree and 6+ years of relevant experience
  • Experience in diagnostic, pharmaceutical, or medical device industry
  • Knowledge of international CMC regulatory requirements and highly-regulated environments
  • Background in pharmaceutical sciences, chemistry, or analytical sciences
  • Experience with electronic document management and quality management systems
  • Demonstrated ability to prioritize and plan deliverables aligned with strategic goals

Compensation: $106,400-$159,600 annual

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