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.
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
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