Gehc
Senior Director, Regulatory Affairs, Radiopharma
Remote, USA · Director
No sponsorship$198k-$297kDetected 25 days ago
Project ManagementNegotiationBudgetingSupply ChainCorporate LawFDA RegulatoryPharmacovigilanceLeadershipCommunicationProblem SolvingRegulatory Affairs
About the role
- 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.
- 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.
Responsibilities
- Monitor and interpret global regulatory trends, emerging guidances, and agency expectations to inform program design and risk mitigation strategies.
- Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams, ensuring alignment with business objectives, regional requirements, and long‑term portfolio plans.
- 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.
- Lead, mentor, and develop a global team of regulatory professionals across multiple regions, ensuring clear priorities, proper resource allocation, and high‑quality, timely execution.
Requirements
- 12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
- Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with 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.
- Experience in sterile injectables, diagnostics, or radiopharmaceuticals.
- Strong communication and negotiation skills, with ability to influence executives and regulators.
Nice to have
- advanced degree strongly preferred.
- Preferred / Desired Characteristics
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field
Compensation
- 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.
Benefits
- Health Authority Engagement & Advocacy
- Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading high‑stakes negotiations and ensuring high‑quality briefing packages and responses.
- 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.
Company info
- 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.
Visa & Work Authorization
- GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.
This listing is sourced directly from Gehc's careers page and normalized into a canonical job model.