Senior Director, Regulatory Affairs, Radiopharma

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $198k - $297k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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. • 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. • Lead, mentor, and develop a global team of regulatory professionals across multiple regions. • Ensure global compliance across development, submissions, registration maintenance, and post-market activities. • Support due diligence activities for partnerships, acquisitions, and in-licensing opportunities by assessing regulatory risks, pathways, and development strategies.

🎯 Requirements

• 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. • Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with Fast Track, Orphan Designation, Priority and Rolling Review. • 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.

🏖️ Benefits

• medical, dental, vision • paid time off • 401(k) plan with employee and company contribution opportunities • life insurance • disability insurance • accident insurance • tuition reimbursement