Director, Regulatory Affairs, Marketed Products - Radiopharma

GE HealthCare • United States, United States • 1d ago

Job Description Summary

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.

Job Description

Key Responsibilities:

Strategic Leadership & Influence

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.

Leadership & Team Management

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.

Global Lifecycle Management & Regulatory Strategy

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.

Cross-Functional Collaboration

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.

Operational Excellence & Delivery

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.

Compliance & Inspection Readiness

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.

Required Qualifications

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.

Desired Characteristics

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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $153,600.00-$230,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: July 03, 2026

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