Gehc

Director, Regulatory Affairs, Marketed Products - Radiopharma

Remote, USA · Director

No sponsorship$154k-$230kDetected 25 days ago

ComplianceStakeholder ManagementSupply ChainFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

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.
GE HealthCare is an Equal Opportunity Employer.
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.

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.
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.
Promote adoption of digital tools and AI, building team capability in these areas.
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).
Optimize submission strategies, sequencing, and timelines across markets.
Anticipate regulatory risks and implement proactive mitigation plans.

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.
Strong strategic thinking and ability to translate regulatory complexity into business value.

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.

Ensure compliance with global regulatory requirements and evolving health authority expectations.
Work closely with Quality, Supply Chain, Safety, Medical Affairs, and Commercial functions to align regulatory activities with business and supply priorities.
Ensure all regulatory activities comply with global health authority requirements and internal standards.

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.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

This listing is sourced directly from Gehc's careers page and normalized into a canonical job model.