7+ years regulatory experience in pharmaceutical field
Leading us nda/bla licensing submissions
Pan european regulatory submission expertise
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GE HealthCare Technologies is seeking a Global Regulatory Lead for its Pharmaceutical Diagnostics division. The role involves overseeing regulatory strategy for developing diagnostic products targeting neurodegenerative diseases, cardiac function, and oncology.
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Job Summary
This role serves as the single point of accountability for Global Regulatory Strategy Leadership and policy development for pharmaceutical diagnostics.
The position requires leading successful US NDA/BLA licensing submissions and Pan European regulatory processes while ensuring timely input to global development programs.
GE HealthCare offers a competitive benefits package including medical, dental, vision, paid time off, and a 401(k) plan with company contribution opportunities.
Matching Summary
Match Score: 75
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GE HealthCare Technologies is seeking a Global Regulatory Lead for its Pharmaceutical Diagnostics division. The role involves overseeing regulatory strategy for developing diagnostic products targeting neurodegenerative diseases, cardiac function, and oncology.
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Salary
Base: $153,600.00-$230,400.00 Annual; Bonus/Equity: Performance based incentive compensation including cash bonus(es) and/or long term incentives (LTI); Benefits: Medical, dental, vision, paid time off, 401(k), life, disability, accident insurance, tuition reimbursement
Skills & Requirements
Must-have
7+ years regulatory experience in pharmaceutical field
Leading US NDA/BLA licensing submissions
Pan European regulatory submission expertise
Clinical related regulations guidance knowledge
Stakeholder influence and motivation skills
Nice-to-have
Knowledge of preclinical and CMC development
Ability to drive new regulatory approaches
Experience with global regulatory strategy documents
Track record of successful agency interactions
Key Requirements
Bachelor's Degree in Science, Biotech, Engineering or related field
7+ years of experience in regulatory affairs
Proven track record of leading US NDA/BLA submissions
Legally authorized to work in the United States
Work Rights
Must be legally authorized to work in the United States