Director, Regulatory Affairs, Marketed Products - Radiopharma

GE HealthCare

2d•$153,600 - $230,400•Onsite

About The Position

The Director of Marketed Products, Radiopharma reports to the Senior Director, RA – Radiopharma and is responsible for leading a global team managing all post-approval lifecycle activities for radiopharmaceutical products across worldwide markets. This role ensures regulatory compliance, drives forward-looking lifecycle and portfolio optimization strategies, enables the efficient execution of variations, renewals, and maintenance activities while collaborating closely with RA-CMC and NPI teams to support product continuity and lifecycle strategy.

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.

Nice To Haves

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.

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.