Associate Director, Global Regulatory Affairs

Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

We are a healthcare company, pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the‑art computer science and data science to overcome one of medicine’s greatest challenges.

GRAIL is headquartered in the bay area of California, with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies.

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The Associate Director, Global Regulatory Affairs supports the vision, and strategic direction for the company’s global regulatory function. This role reports to the Vice President, Head of Regulatory and is accountable for driving regulatory strategy across all portfolios—with a focus on diagnostics and device commercialization, influencing external regulatory policy, and ensuring global compliance in alignment with corporate objectives. The Associate Director/Director partners closely with executive leadership to guide portfolio and business‑critical decisions, supports the company by preparing materials and presentations required for high‑level interactions with health authorities, and develops the next generation of regulatory leaders.

This is a hybrid role based in Washington, D.C. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on‑site. Your specific schedule, determined in collaboration with your manager, will align with the team and business needs and could exceed the 40% requirement for the site.

Responsibilities:

• Define and oversee global regulatory strategies for the company’s full product portfolio, ensuring alignment with business priorities and global requirements.
• Drive diagnostics and or medical device commercialization across key international markets, specifically the EU, Asia/Pacific, the Middle East (including Israel and Saudi Arabia), and the UK.
• Working closely with Senior executives, provide strategy and oversight for all regulatory submissions, product approvals, and lifecycle management activities across geographies.
• Partner with cross‑functional teams, and executive leadership (R &D, Quality, Clinical, Commercial, Manufacturing) to integrate regulatory considerations into enterprise strategy and portfolio governance.
• Anticipate global regulatory and policy shifts, assess impact, and shape proactive company responses.
• Ensure organizational readiness for regulatory inspections, audits, and authority interactions at the highest level.
• Influence international regulatory policy through participation in industry forums, standards bodies, and regulatory working groups.
• Champion innovation and transformation initiatives within the regulatory function, including digital enablement, automation, and process modernization.

Required Qualifications:

• Advanced degree in molecular biology, genomics, or diagnostics;
  PhD preferred.
• 15+ years of relevant regulatory affairs or related industry experience;
  Master’s degree with 12+ years, or PhD with 10+ years
• Proven record of success leading enterprise‑level regulatory strategies and high‑impact submissions, particularly with experience in international diagnostics/device commercialization.
• Extensive experience interacting at senior levels with global regulatory agencies and influencing international…