Job Overview
Location
Remote
Job Type
Full-time
Category
HR & Recruiting
Date Posted
March 31, 2026
Full Job Description
đź“‹ Description
- • As a Global Regulatory Lead for GE HealthCare's Pharmaceutical Diagnostics (PDx) business, you will serve as the primary regulatory authority and strategic leader for the development and global registration of molecular imaging agents and contrast media, including tracers for neurodegenerative diseases, cardiac function, and oncology tumor expression. You will be the single point of accountability for global regulatory strategy, ensuring alignment across pre-clinical, clinical, and registration phases to support timely market access in key international regions.
- • You will lead the development and execution of regulatory strategies for assigned global programs, coordinating closely with National Regulatory Affairs (NRA) teams to ensure submission readiness, timely input into development plans, and proactive identification of regulatory opportunities, risks, and mitigation strategies throughout the product lifecycle.
- • You will guide, influence, and motivate cross-functional internal and external stakeholders—including R&D, clinical, quality, and commercial teams—to align with GE HealthCare’s business objectives and project timelines, ensuring regulatory compliance is integrated into decision-making without compromising innovation or patient safety.
- • You will be responsible for fulfilling all regulatory affairs (RA) compliance obligations, including preparing and supporting global submissions such as US NDAs/BLAs, European CP/DCP/MRP procedures, and national filings, while maintaining rigorous adherence to evolving clinical, CMC, and preclinical regulatory guidance.
- • You will act as the primary liaison with global regulatory agencies (e.g., FDA, EMA, PMDA, NMPA) and key external stakeholders, leveraging your expertise to drive constructive interactions, anticipate agency expectations, and advocate for science-based regulatory pathways that accelerate patient access to innovative diagnostics.
- • You will champion innovative regulatory approaches to streamline development timelines, improve submission quality, and enhance efficiency in response to evolving scientific and regulatory landscapes, ensuring PDx remains at the forefront of molecular imaging innovation while meeting unmet patient needs.
🎯 Requirements
- • Bachelor’s Degree in Science, Biotechnology, Engineering, or a closely related scientific field
- • 7+ years of progressive experience in regulatory affairs, with demonstrated preference for expertise in the pharmaceutical or biologics industry
- • Proven track record of successfully leading US NDA/BLA licensing submissions and managing complex European regulatory pathways, including Centralized (CP), Decentralized (DCP), and Mutual Recognition (MRP) procedures, as well as national agency interactions
- • Demonstrated expertise in navigating clinical, CMC, and preclinical regulatory frameworks as they apply to diagnostic imaging agents and molecular tracers, with ability to interpret and apply guidance from FDA, EMA, ICH, and other global authorities
- • Exceptional interpersonal and communication skills, with proven ability to convey complex regulatory concepts clearly and persuasively to diverse internal and external audiences, including senior leadership, scientists, clinicians, and agency representatives
🏖️ Benefits
- • Competitive base salary within the range of $153,600.00–$230,400.00 annually, commensurate with experience and qualifications, plus eligibility for performance-based incentives including cash bonuses and long-term equity awards
- • Comprehensive health and wellness benefits, including medical, dental, and vision coverage, supplemented by life, disability, and accident insurance plans
- • Retirement savings support through a 401(k) plan with both employee and company contribution matching opportunities to help build long-term financial security
- • Tuition reimbursement program to support continuous learning and professional development in regulatory science, healthcare innovation, or related fields
- • Access to GE HealthCare’s global career mobility, professional development resources, and inclusive culture that emphasizes care, collaboration, integrity, and ownership—enabling growth in a purpose-driven organization dedicated to improving patient outcomes worldwide
Skills & Technologies
Senior
Remote
Degree Required
About GE HealthCare Technologies Inc.
GE HealthCare Technologies Inc. designs, manufactures and services medical imaging, diagnostics, monitoring and life-care equipment for hospitals, clinics and research institutions worldwide. The company’s portfolio includes MRI, CT, ultrasound, X-ray and molecular imaging systems, contrast agents, pharmaceutical diagnostics, ventilators and anaesthesia machines, enterprise digital solutions, and after-sales support, training and financing services. Headquartered in Chicago, Illinois, it operates manufacturing, R&D, sales and service facilities across North America, Europe and Asia.
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