GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. Discover our mission to detect cancer early, when it can be cured. Backed by GV.
About the role
Define and oversee global regulatory strategies for the company's product portfolio, ensuring alignment with business priorities and global requirements. Drive Galleri commercialization across key international markets, specifically the EU, Asia/Pacific, the Middle East (including Israel and Saudi Arabia), and the UK.
What they're looking for
- Global regulatory experience with mastery of US, EU, and international frameworks, submission pathways, and compliance requirements
- Exceptional communication and influencing skills, with credibility at the executive and global health authority levels
- Strong portfolio and enterprise decision-making capability, balancing regulatory risk, innovation, and business priorities
- Advanced proficiency in enterprise regulatory systems, global submission platforms, and compliance tools
- Lead the development, preparation, review, and execution of international regulatory submissions and product registrations
- Establish filing strategies, submission plans, timelines, dependencies, and governance necessary to support international commercialization
More about this role
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.
For more information, please visit grail.com
The Director/Associate Director, International 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, influencing external...
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