Director, International Regulatory Strategy

GRAIL; United States; On-site; USD 169,000 - 242,000; Full time

Benefits offered by this job

Flexible time-off or vacation

401(k) retirement plan with employer 


Medical, dental, and vision coverage

Mindfulness programs

Job summary

GRAIL is seeking a Director/Associate Director of International Regulatory Affairs to guide global regulatory strategy for Galleri. You will partner with senior leadership to drive submissions, approvals, and lifecycle management across geographies.

Based in Sunnyvale, DC, or RTP, you will influence policy, shape portfolio strategy, and lead regulatory transformation initiatives while ensuring compliance and readiness for inspections.

Qualifications

• Advanced degree in molecular biology, genomics, or diagnostics.
• 15+ years in regulatory affairs with international exposure.
• Proven track record in enterprise-level regulatory strategies and submissions.
• Experience engaging senior leaders and health authorities.

Responsibilities

• Define and oversee global regulatory strategies for the product portfolio.
• Drive Galleri commercialization across EU, Asia/Pacific, Middle East, and UK.
• Oversee regulatory submissions, approvals, and lifecycle management.
• Partner with R&D, Quality, Clinical, Commercial, and Manufacturing teams.
• Anticipate regulatory shifts and shape proactive company responses.
• Ensure readiness for regulatory inspections and agency interactions.
• Influence international policy through industry forums and working groups.
• Lead digital enablement, automation, and process modernization in regulatory.

Skills

Global regulatory strategy

Executive communication

Regulatory submissions

Cross-functional collaboration

Policy influence

Education

Advanced degree in molecular biology/genomics/diagnostics

PhD preferred

Job description

GRAIL is seeking a Director/Associate Director of International Regulatory Affairs to guide global regulatory strategy for Galleri. You will partner with senior leadership to drive submissions, approvals, and lifecycle management across geographies.

Based in Sunnyvale, DC, or RTP, you will influence policy, shape portfolio strategy, and lead regulatory transformation initiatives while ensuring compliance and readiness for inspections.