Global Regulatory Strategy Director — Diagnostics

GRAIL; Washington (District of Columbia); Ibrido; USD 169.000 - 242.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible time off

401(k) with employer match

Medical, dental, and vision coverage

Descrizione del lavoro

GRAIL, a healthcare company specializing in early cancer detection, seeks a Director/Associate Director, International Regulatory Affairs. This role leads global regulatory strategy, manages high-impact submissions, and partners with senior leadership to guide portfolio decisions across geographies.

The position requires extensive international regulatory experience and close collaboration with R&D, Quality, Clinical, and Manufacturing teams.

Competenze

• 15+ years in regulatory affairs or related industry
• Master's with 12+ years or PhD with 10+ years preferred
• Proven record leading enterprise-level regulatory strategies
• Experience interacting with global regulatory agencies
• Knowledge of regulatory standards (IVD/diagnostics, GMP, HIPAA, GDPR)

Mansioni

• Define and oversee global regulatory strategies for the product portfolio.
• Drive Galleri commercialization across EU, Asia/Pacific, Middle East, UK.
• Lead regulatory submissions and lifecycle management across geographies.
• Collaborate with R&D, Quality, Clinical, Manufacturing and Commercial teams.
• Anticipate regulatory shifts and shape proactive company responses.
• Ensure readiness for inspections and authority interactions at high levels.
• Influence policy through industry forums and standards bodies.
• Champion digital enablement and process modernization in regulatory.
• Lead international registrations and filing strategies.

Conoscenze

Regulatory strategy leadership

Global regulatory engagement

Regulatory submissions (diagnostics)

Executive communication

Regulatory governance & policy

Formazione

PhD in molecular biology/genomics/diagnostics

Advanced degree suitable for regulatory leadership

Strumenti

Enterprise regulatory systems

Regulatory submission platforms

Descrizione del lavoro

GRAIL, a healthcare company specializing in early cancer detection, seeks a Director/Associate Director, International Regulatory Affairs. This role leads global regulatory strategy, manages high-impact submissions, and partners with senior leadership to guide portfolio decisions across geographies.

The position requires extensive international regulatory experience and close collaboration with R&D, Quality, Clinical, and Manufacturing teams.