Global Regulatory Lead, PDx
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.
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.
Job Description
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.
Required Qualifications:
• 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.
Desired Characteristics
• 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.
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.
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.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $153,600.00-$230,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). 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.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: May 25, 2026
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.
Job Description
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.
Required Qualifications:
• 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.
Desired Characteristics
• 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.
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.
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.
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
For U.S. based positions only, the pay range for this position is $153,600.00-$230,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). 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.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
Application Deadline: May 25, 2026