Senior Director, Regulatory Affairs, Radiopharma

Job Description Summary

The Senior Director of Regulatory Affairs, Radiopharma serves as a senior global leader within the Pharmaceutical Diagnostics (PDx) Regulatory Affairs organization, reporting to the Global Head of Regulatory Affairs. This role provides end‑to‑end regulatory leadership across drug development, registration, lifecycle management, compliance, and CMC for key markets including the United States, while supporting global regulatory strategy, governance, and operational excellence. The Senior Director leads a multi‑regional team of global regulatory professionals and partners closely with regulatory regional teams and cross‑functional leaders to advance the PDx product portfolio efficiently and compliantly.

Key Responsibilities

• Global Regulatory Strategy & Execution
• Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in the U.S. and other priority markets, ensuring alignment with business objectives, regional requirements, and long‑term portfolio plans.
• Provide strategic guidance from early development to registration and lifecycle, leveraging expertise across CMC, non‑clinical, clinical, and quality domains.
• Monitor and interpret global regulatory trends, emerging guidances, and agency expectations to inform program design and risk mitigation strategies.
• Health Authority Engagement & Advocacy
• Serve as the senior regulatory lead in interactions with major health agencies including the FDA, leading high‑stakes negotiations and ensuring high‑quality briefing packages and responses.
• Represent the organization in global regulatory forums and external industry groups to influence evolving regulations and advocate for PDx‑relevant policy positions.
• Cross‑Functional & Global Program Leadership
• Partner with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirements into global product strategies, development plans, and launch readiness.
• Communicate effectively the opportunities and risks of proposed regulatory strategies.
• Team Leadership & Organizational Development
• Lead, mentor, and develop a global team of regulatory professionals across multiple regions, ensuring clear priorities, proper resource allocation, and high‑quality, timely execution.
• Foster a culture of compliance, agility, scientific excellence, and proactive problem‑solving, consistent with the expectations for senior leadership roles.
• Regulatory Governance, Compliance & Quality Systems
• Ensure global compliance across development, submissions, registration maintenance, and post‑market activities.
• Oversee preparation, accuracy, and maintenance of global regulatory dossiers, ensuring alignment across regions and adherence to corporate governance expectations.
• Lead continuous‑improvement initiatives to enhance regulatory efficiency, operational excellence, and risk management.
• Business Partnership & Strategic Support
• Support due diligence activities for partnerships, acquisitions, and in‑licensing opportunities by assessing regulatory risks, pathways, and development strategies.
• Contribute to regulatory budgeting, long‑range planning, and strategic portfolio prioritization.

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree strongly preferred.
• 12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
• Demonstrated success supporting or leading regulatory strategy and submissions in the U.S. and other highly regulated agencies such as Japan, China, and the EU, across development, approval, and lifecycle phases.
• Proven experience navigating U.S. FDA requirements, regulations and pathways—including Fast Track, Orphan Designation, Priority and Rolling Review, etc.
• Strong expertise in Clinical and CMC regulatory strategy, with hands‑on experience guiding Clinical and CMC teams through development, registration, and global change management.
• Proven experience managing and developing regulatory teams across multiple regions.
• Deep understanding of global regulatory frameworks from IND/CTA through marketing approval, post‑approval changes, compliance, and pharmacovigilance‑related requirements.

Preferred / Desired Characteristics

• Experience in sterile injectables, diagnostics, or radiopharmaceuticals.
• Excellent strategic thinking, systems‑level problem‑solving, and decision‑making abilities.
• Strong communication and negotiation skills, with ability to influence executives and regulators.
• Excellent project management and organization skills; capable of leading multiple complex programs simultaneously.

Benefits

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 $198,000.00–$297,000.00 Annual. Compensation decisions are dependent on the facts and circumstances of each case. The 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 medical, dental, vision, paid time off, a 401(k) plan with employee and company contributions, 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: July 09, 2026