Global Regulatory Lead, PDx

GE HealthCare

3d

About The Position

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. 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.

Requirements

• Bachelor’s Degree in Science, Biotech, Engineering or related field
• 7+ years of experience in regulatory, preferably in the pharmaceutical field
• Proven track record of leading successful US NDA/BLA licensing submissions and Pan European (CP, DCP, MRP), European national.
• Proven track record of leading successful interaction with regulatory agencies and relevant stakeholders.
• Proven expertise with clinical related regulations/guidance as it relates to development of product submissions.
• Ability to clearly convey and exchange information with internal and external stakeholders.

Nice To Haves

• 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.

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.

Benefits

• 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.
• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level