Global Regulatory Strategy Director

GRAIL; Sunnyvale (CA); On-site; USD 169,000 - 242,000; Full time

Benefits offered by this job

Flexible time off

401(k) employer match

Medical coverage

Dental coverage

Vision coverage

Well-being programs

Job summary

GRAIL is seeking a Director/Associate Director of International Regulatory Affairs to shape global regulatory strategy across a multi-market portfolio. You will work with executive leadership to guide submissions, approvals, and lifecycle management, ensuring readiness for inspections and interactions with health authorities.

Based in Sunnyvale or DC or RTP, the role requires substantial international experience, advanced degrees, and strong influence with global regulators.

Qualifications

• Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred.
• 15+ years of relevant regulatory affairs experience; Master's with 12+ years, or PhD with 10+ years.
• Proven record leading enterprise-level regulatory strategies and submissions, esp. international diagnostics/device commercialization.
• Extensive experience with senior-level interactions with global regulatory agencies and policy influence.
• Knowledge of medical device submissions (IVDD/IVDR/FDA 21 CFR/UK MDR).
• ISO 13485 GMP, ISO 14971 risk, CAP/CLIA/NYSDOH/ISO 15189, HIPAA/GDPR compliance.

Responsibilities

• Define and oversee global regulatory strategies for the product portfolio.
• Drive commercialization in EU, Asia-Pacific, Middle East, and UK.
• Lead regulatory submissions, product approvals, and lifecycle management across geographies.
• Collaborate with R&D, Quality, Clinical, Commercial, and Manufacturing to align regulatory needs.
• Anticipate regulatory shifts and shape proactive company responses.
• Ensure readiness for inspections and authority interactions at the highest level.

Skills

Global regulatory strategy

Executive communication

Regulatory submissions

Regulatory policy

Cross-functional collaboration

Education

Advanced degree in molecular biology/genomics/diagnostics

PhD preferred

Job description

GRAIL is seeking a Director/Associate Director of International Regulatory Affairs to shape global regulatory strategy across a multi-market portfolio. You will work with executive leadership to guide submissions, approvals, and lifecycle management, ensuring readiness for inspections and interactions with health authorities.

Based in Sunnyvale or DC or RTP, the role requires substantial international experience, advanced degrees, and strong influence with global regulators.