Director, Regulatory Affairs, Marketed Products - Radiopharma

GE HealthCare is a leading company in the healthcare sector, and they are seeking a Director of Marketed Products for their Radiopharma division. This role involves leading a global team to manage post-approval lifecycle activities for radiopharmaceutical products, ensuring regulatory compliance and driving strategic initiatives for product continuity and optimization.

Responsibilities:

• Define and drive the global lifecycle regulatory strategy aligned with corporate, portfolio, and product objectives, ensuring supply continuity and business value
• Act as a strategic partner to senior leadership, communicating risks, opportunities, and regulatory scenarios to influence decision-making
• Represent the lifecycle regulatory function in governance forums and cross-functional leadership discussions
• Lead, coach, and develop a high-performing global regulatory team
• Set clear objectives and drive accountability for timely, high-quality delivery
• Manage resources, capabilities, and workload planning to meet portfolio priorities
• Foster a collaborative, inclusive, and performance-driven culture
• Promote adoption of digital tools and AI, building team capability in these areas
• 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
• Lead the development and execution of global regulatory strategies for geographic expansion into new markets and label expansions (e.g.: new indications, formulations, populations)
• Ensure compliance with global regulatory requirements and evolving health authority expectations
• Optimize submission strategies, sequencing, and timelines across markets
• Anticipate regulatory risks and implement proactive mitigation plans
• Partner with RA-CMC to align regulatory strategies for technical and manufacturing changes
• Collaborate with NPI to ensure seamless transition from development to lifecycle management and influence maintainability of registration strategies
• Work closely with Quality, Supply Chain, Safety, Medical Affairs, and Commercial functions to align regulatory activities with business and supply priorities
• Act as the key interface with regional and local regulatory teams
• Ensure timely, high-quality execution of lifecycle submissions through effective planning, tracking, and team accountability
• Drive standardization and simplification of lifecycle management processes
• Monitor KPIs to ensure delivery performance and continuous improvement
• Drive adoption of AI and digital solutions to enhance regulatory intelligence, submission processes and decision-making, including partnering with Digital/IT to implement scalable regulatory technology solutions
• Ensure all regulatory activities comply with global health authority requirements and internal standards
• Maintain inspection readiness and support responses to regulatory queries and audits
• Ensure proper documentation, archiving, and traceability of regulatory activities

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
• Strong strategic thinking and ability to translate regulatory complexity into business value
• Excellent stakeholder influence and communication skills
• Ability to manage complexity, prioritize effectively, and drive decisions
• High level of agility, problem-solving, and resilience in a global environment
• Digital and innovation mindset, including openness to AI adoption