Director, Global & International Regulatory Affairs #4810

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

Responsibilities

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

Adaptability and Growth Expectation

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

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Taking on additional responsibilities.

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Participating in cross functional projects and initiatives.

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Adapting to new technologies, processes, or methodologies.

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Supporting other departments or teams during periods of high demand.

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Contributing to special projects or temporary assignments as needed.

These job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Required Qualifications

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Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.

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15+ years of relevant regulatory affairs or related industry experience; Master’s degree with 13+ years, or PhD with 10+ years.

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Demonstrated success leading regulatory strategy across multiple portfolios and therapeutic areas.

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Extensive experience interacting with global regulatory authorities, including FDA, EMA, and other agencies.

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Proven track record of developing and leading high-performing teams.

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Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:

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GMP quality management systems (e.g. ISO 13485)

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Risk assessment frameworks (e.g. ISO 14971)

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Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

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Protected health information (e.g. HIPAA, GDPR)

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Regulatory submission of medical devices (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002)

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Development and Operations within a regulated clinical study environment (e.g. ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)

Preferred Qualifications

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• Recognized regulatory expert with broad and deep knowledge of U.S., EU, and global regulatory frameworks.
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• Exceptional leadership skills, with the ability to inspire, align, and influence at all organizational levels.
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• Strong strategic foresight with the ability to anticipate regulatory and policy shifts and align company direction.
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• Excellent communication, negotiation, and executive presentation skills.
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• Proven ability to lead complex programs and drive portfolio-level decision-making.
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• Advanced proficiency with regulatory systems, submission tools (e.g., eCTD), and enterprise compliance platforms.
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• Commitment to developing talent and building long-term organizational capability.

Physical Demands and Working Environment

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• Executive-level role with broad global scope and high visibility.
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• Requires availability across time zones and flexibility to meet international submission and authority deadlines.
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• Work involves frequent interaction with global health authorities, senior executives, and industry leaders.
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• Frequent domestic and international travel required for regulatory meetings, conferences, and leadership engagements.