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Director, Regulatory Affairs – Market Products, Radiopharma
GE HealthCareDirector of Regulatory Affairs leading lifecycle management of radiopharmaceutical products at GE HealthCare. Ensuring regulatory compliance and strategic leadership while collaborating globally.
About the role
Key responsibilities & impact- Define and drive the global lifecycle regulatory strategy aligned with corporate, portfolio, and product objectives
- Act as a strategic partner to senior leadership, communicating risks, opportunities, and regulatory scenarios
- Lead, coach, and develop a high-performing global regulatory team
- Oversee all post-approval regulatory activities, including variations, renewals, and regulatory commitments
- Lead regulatory strategy for post-approval changes, including impact assessment, pathway optimization, and risk mitigation
- Ensure compliance with global regulatory requirements and evolving health authority expectations
- Partner with RA-CMC to align regulatory strategies for technical and manufacturing changes
- Ensure timely, high-quality execution of lifecycle submissions through effective planning, tracking, and team accountability
Requirements
What you’ll need- Bachelor’s or advanced degree in Life Sciences, Pharmacy, Chemistry, or related field
- 7+ years of regulatory affairs experience with strong focus on post-approval lifecycle management
- Proven experience working in cross-functional global environments
- Leadership experience managing teams
- Strong strategic, communication, and stakeholder management skills
Benefits
Comp & perks- medical
- dental
- vision
- paid time off
- a 401(k) plan with employee and company contribution opportunities
- life insurance
- disability
- accident insurance
- tuition reimbursement
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategylifecycle managementpost-approval activitiesimpact assessmentpathway optimizationrisk mitigationcomplianceregulatory submissionsteam accountability
Soft Skills
leadershipcoachingcommunicationstakeholder managementstrategic thinking
Certifications
Bachelor’s degreeadvanced degree