Strategic CMC Regulatory Lead for Diagnostics

GE HealthCare; United States; Remote; USD 106,000 - 160,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, dental, vision benefits

Paid time off

Job summary

GE HealthCare is seeking a Senior Regulatory Manager to provide CMC regulatory input and develop strategies for development projects and marketed products. This role focuses on maintaining Quality sections in product dossiers across the lifecycle and collaborates with global RA teams to address regulatory questions.

The candidate will stay updated on CMC guidelines, support audits, and contribute to a matrix organization to drive decisions and ensure compliant submissions.

Qualifications

• Bachelor's degree and 6+ years in diagnostic/pharma/medical device industries.
• Experience in regulated CMC environment and QA.
• Experience with electronic document management and Quality systems.
• Knowledge of international CMC regulatory requirements.

Responsibilities

• Provide CMC regulatory input for projects/products.
• Define submission strategy documents and data requirements.
• Guide project teams on data collection for global submissions.
• Review and edit CMC dossier sections for regulatory submissions.

Skills

CMC regulatory

Project planning

Regulatory submissions

Documentation management

Quality systems

International regulatory knowledge

Education

Bachelor's degree

Master's degree

Tools

Veeva RIM

Job description

GE HealthCare is seeking a Senior Regulatory Manager to provide CMC regulatory input and develop strategies for development projects and marketed products. This role focuses on maintaining Quality sections in product dossiers across the lifecycle and collaborates with global RA teams to address regulatory questions.

The candidate will stay updated on CMC guidelines, support audits, and contribute to a matrix organization to drive decisions and ensure compliant submissions.