Global Regulatory Affairs Director – Diagnostics (Intl)

GRAIL; Washington (District of Columbia); Hybrid; USD 169,000 - 242,000; Full time

Benefits offered by this job

Flexible work arrangements

Competitive benefits package

401(k) retirement plan with company"s

Mindfulness programs

Job summary

GRAIL seeks a Director/Associate Director, International Regulatory Affairs to shape global regulatory strategy and drive submissions for a diverse portfolio. You will partner with senior leaders to align regulatory plans with business objectives and guide critical decisions across geographies.

You will influence international policy, manage high-stakes interactions with health authorities, and ensure readiness for inspections, while leading transformation within the regulatory function.

Qualifications

• Advanced degree in molecular biology, genomics, or diagnostics.
• 15+ years of regulatory affairs experience; masters with 12+ or PhD with 10+ years.
• Proven success leading enterprise-level regulatory strategies and submissions.
• Extensive experience interacting with global regulatory agencies.
• Knowledge of medical device regs, GMP, CAP/CLIA, HIPAA and GDPR.

Responsibilities

• Define and oversee global regulatory strategies for the product portfolio.
• Drive international commercialization across EU, APAC, ME, and UK.
• Oversee regulatory submissions, product approvals, and lifecycle management.
• Collaborate with R&D, Quality, Clinical, Commercial, and Manufacturing teams.
• Prepare materials for high-level interactions with health authorities.
• Anticipate regulatory shifts and readiness for inspections.
• Guide governance and portfolio decisions with executive leadership.

Skills

Regulatory strategy

Global regulatory experience

Executive communication

Policy influence

Education

PhD in molecular biology/genomics/diagnostics

Master's degree in related field

Job description

GRAIL seeks a Director/Associate Director, International Regulatory Affairs to shape global regulatory strategy and drive submissions for a diverse portfolio. You will partner with senior leaders to align regulatory plans with business objectives and guide critical decisions across geographies.

You will influence international policy, manage high-stakes interactions with health authorities, and ensure readiness for inspections, while leading transformation within the regulatory function.