• 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.