Director, Global Regulatory Strategy (International)

Initial Therapeutics, Inc.; Washington (District of Columbia); Hybrid; USD 169,000 - 242,000; Full time

Benefits offered by this job

Flexible time-off

401(k) with employer match

Medical/dental/vision coverage

Job summary

GRAIL is seeking a Director/Associate Director, International Regulatory Affairs to shape global regulatory strategy and drive submissions for a portfolio of diagnostics devices, reporting to the VP Head of Regulatory. The role partners closely with senior leadership to guide portfolio decisions and prepare materials for regulatory interactions across geographies.

The position requires extensive international regulatory experience, leading complex submissions, and the ability to influence policy

Qualifications

• Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred.
• 15+ years of regulatory affairs or related industry experience; Master's with 12+ years, or PhD with 10+ years.
• Proven record of leading enterprise-level regulatory strategies and high-impact submissions.

Responsibilities

• Define and oversee global regulatory strategies for the product portfolio to align with business priorities.
• Drive Galleri commercialization across key international markets (EU, Asia/Pacific, Middle East, UK).
• Lead regulatory submissions, product approvals, and lifecycle management across geographies.
• Partner with R&D, Quality, Clinical, Commercial, and Manufacturing to integrate regulatory considerations into enterprise strategy.
• Prepare materials for high-level interactions with health authorities and inspections.

Skills

Regulatory strategy

Global regulatory leadership

Executive stakeholder communication

Regulatory submissions

Education

PhD in molecular biology/genomics/diagnostics

Master’s degree with 12+ years experience

Tools

Enterprise regulatory systems

Global submission platforms

Compliance tools

Job description

GRAIL is seeking a Director/Associate Director, International Regulatory Affairs to shape global regulatory strategy and drive submissions for a portfolio of diagnostics devices, reporting to the VP Head of Regulatory. The role partners closely with senior leadership to guide portfolio decisions and prepare materials for regulatory interactions across geographies.

The position requires extensive international regulatory experience, leading complex submissions, and the ability to influence policy