Job Description SummaryAs 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.

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 submissionsProven 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 submissionsKnowledge 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.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

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

 

Inclusion & Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

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Additional Information

Relocation Assistance Provided: No