Senior Director, Regulatory Affairs, Radiopharma

GE HealthCare

Senior Director leading global regulatory strategies and managing multi-regional teams in healthcare. Overseeing regulatory compliance and engaging with health authorities for product approvals.

Posted 6/26/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $198,000 - $297,000 per yearWebsite

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

regulatory strategyglobal regulatory affairsclinical regulatory strategyCMC regulatory strategyFDA requirementsFast TrackOrphan DesignationPriority ReviewRolling Reviewpharmacovigilance

Soft Skills

leadershipmentoringteam developmentnegotiationcollaborationcommunicationstrategic thinkingproblem-solvingorganizational skillscross-functional teamwork

Industry Keywords

Life SciencesPharmacyChemistryIND/CTAmarketing approvalpost-approval changescomplianceglobal change managementdue diligenceregulatory risks

About the role

Key responsibilities & impact

Develop, oversee and drive global regulatory strategies for assigned development programs and marketed products in US, and other priority markets supported by the regional regulatory teams.
Serve as the senior regulatory lead in interactions with major health agencies including FDA, leading high-stakes negotiations and ensuring high-quality briefing packages and responses.
Partner with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to integrate regulatory requirements into global product strategies, development plans, and launch readiness.
Lead, mentor, and develop a global team of regulatory professionals across multiple regions.
Ensure global compliance across development, submissions, registration maintenance, and post-market activities.
Support due diligence activities for partnerships, acquisitions, and in-licensing opportunities by assessing regulatory risks, pathways, and development strategies.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree strongly preferred.
12+ years of global regulatory affairs experience, including leadership roles with increasing responsibility.
Proven experience navigating US FDA requirements, regulations and pathways including but not limited to experience with Fast Track, Orphan Designation, Priority and Rolling Review.
Strong expertise in Clinical and CMC regulatory strategy, with hands-on experience guiding Clinical and CMC teams through development, registration, and global change management.
Proven experience managing and developing regulatory teams across multiple regions.
Deep understanding of global regulatory frameworks from IND/CTA through marketing approval, post-approval changes, compliance, and pharmacovigilance-related requirements.

Benefits

Comp & perks

medical, dental, vision
paid time off
401(k) plan with employee and company contribution opportunities
life insurance
disability insurance
accident insurance
tuition reimbursement