Global Regulatory Strategy Director

GRAIL; Washington (District of Columbia); Hybrid; USD 169,000 - 242,000; Full time

Job summary

GRAIL is seeking a Director of Regulatory Affairs to lead global regulatory strategies across multiple portfolios, ensuring compliance with international regulations and representing the company with health authorities and industry bodies.

Based in Washington, DC, this hybrid role requires 40% on-site work and offers leadership of a high‑performing team, oversight of submissions and lifecycle management, and opportunities to influence enterprise strategy and policy engagement.

Qualifications

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

Responsibilities

• 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.

Skills

Regulatory strategy

Global authorities

Team leadership

Strategic influence

Education

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

Master’s degree with 13+ years

PhD with 10+ years

Demonstrated regulatory knowledge

Tools

Regulatory systems

eCTD submission tools

Job description

GRAIL is seeking a Director of Regulatory Affairs to lead global regulatory strategies across multiple portfolios, ensuring compliance with international regulations and representing the company with health authorities and industry bodies.

Based in Washington, DC, this hybrid role requires 40% on-site work and offers leadership of a high‑performing team, oversight of submissions and lifecycle management, and opportunities to influence enterprise strategy and policy engagement.