Director, Global & International 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 Director, Regulatory Affairs provides leadership and strategic direction for the company’s regulatory affairs function. This role is accountable for shaping global regulatory strategies across multiple portfolios, ensuring compliance with international regulations, and representing the company with regulatory agencies and industry organizations. The Director drives innovation and operational excellence in regulatory processes, develops future regulatory leaders, and plays a critical role in shaping portfolio and enterprise decision‑making.

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.

• Define and lead global regulatory strategies for multiple therapeutic areas, product lines, or technology platforms.
• Serve as the company’s senior regulatory representative in global interactions with health authorities, policymakers, and industry forums.
• Lead, inspire, and develop a high‑performing regulatory affairs team, including senior managers and associate directors.
• Provide oversight for regulatory submissions, approvals, and lifecycle management across global markets.
• Partner with senior executives and cross‑functional leaders to integrate regulatory perspectives into corporate strategy, portfolio prioritization, and business development.
• Anticipate and interpret emerging global regulatory trends, policies, and requirements; shape company strategy and external policy engagement accordingly.
• Ensure compliance with all applicable global regulatory requirements and readiness for audits, inspections, and authority reviews.
• Oversee regulatory contributions to labeling, advertising, and promotional compliance at a global level.
• Drive regulatory innovation, digital transformation, and process improvements to enhance efficiency, quality, and compliance.
• Mentor, coach, and sponsor regulatory leaders, fostering career growth and building a strong succession pipeline.

As our organization continues to evolve and grow, this role may require flexibility in responsibilities and duties. Employees should expect that their role may expand, shift, or be modified to meet changing business needs, strategic priorities, and organizational objectives.

This may include:

• Taking on additional responsibilities.
• Participating in cross functional projects and initiatives.
• Adapting to new technologies, processes, or methodologies.
• Supporting other departments or teams during periods of high demand.
• Contributing to special projects or temporary assignments as needed.

These job duties are a summary of the primary duties and…