Director, Regulatory Affairs – Market Products, Radiopharma
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Job Description
Director of Regulatory Affairs leading lifecycle management of radiopharmaceutical products at GE HealthCare. Ensuring regulatory compliance and strategic leadership while collaborating globally.
Responsibilities:
- 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:
- 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:
- medical
- dental
- vision
- paid time off
- a 401(k) plan with employee and company contribution opportunities
- life insurance
- disability
- accident insurance
- tuition reimbursement
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