JOB DESCRIPTION SUMMARY

As a Global Regulatory Lead, you will contribute to the development, from pre-clinical through clinical studies to initial registration in key global markets, of pharmaceutical diagnostics. This includes ‘tracers’ targeting biomarkers of neurodegenerative diseases, cardiac function and oncology tumor expression. You will be ‘the face’ of the Global Regulatory function on cross-functional global project teams for new product introductions and single point of accountability for Global Regulatory Strategy Leadership and policy development. You will work remotely, based in Europe.

JOB DESCRIPTION

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

BASIC REQUIREMENTS

• Proven track record of leading successful Pan European (CP, DCP, MRP), European national and US NDA/BLA licensing submissions
• Proven track record of leading successful interaction with HA and relevant stakeholders.
• Proven expertise with clinical related regulations/guidance as it relates to development of product submissions.
• Knowledge of preclinical and CMC as it relates to development of product submissions
• Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
• Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs.
• Ability to clearly convey and exchange information with internal and external stakeholders.

• Lead assigned global program development regulatory strategy and co-ordinate with National Regulatory Affairs (NRA) regulatory submission readiness.
• Working with NRA, ensure timely GRA input to global development programs.
• For assigned programs/projects, identify regulatory opportunities, potential risks, and mitigations.
• Guide, influence and motivate, internal and external stakeholders to meet GE HealthCare business and development project team objectives.
• Fulfillment of RA compliance obligations.