GE HealthCare Global Regulatory Lead 

Remote, Remote 

56800355

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.

Essential Responsibilities

• 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.

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.
• Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery.
• Knowledge of preclinical, CMC, clinical related regulations/guidance as it relates to development product submissions.
• 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.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support