Director, Regulatory Affairs – Market Products, Radiopharma

🔥 25 minutes ago

🇺🇸 United States – Remote

💵 $153.6k - $230.4k / year

⏰ Full Time

🔴 Lead

🚔 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

• 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