Director/ Associate Director, International Regulatory Affairs #4809

grailbio · Sunnyvale, CA · 1 month ago

Work mode: Remote
Employment: Full time
Category: Legal
Experience: 10+ years

automation data-science gcp gdpr hipaa iso-13485 risk-assessment

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

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 regulatory policy, and ensuring global compliance in alignment with corporate objectives. The Director partners closely with executive leadership to guide portfolio and business-critical decisions, prepare materials and presentations required for high-level interactions with health authorities, and develop the next generation of regulatory leaders.

This role could be based either in Sunnyvale, DC or RTP. Our current flexible work arrangement policy in the UK 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 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.
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 interactions with authorities 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 policy.
Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity, including
Regulatory submission of medical devices (e.g., IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
GMP quality management systems (e.g., ISO 13485) and Risk assessment frameworks (e.g., ISO 14971)
Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
Protected health information (e.g., HIPAA, GDPR)
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:

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.
Ensure appropriate maintenance of regional registrations and compliance with applicable regulatory databases and registration systems, including:
EU EUDAMED requirements for device registration and UDI;
Saudi Arabian regulatory registration systems, including GHAD, and
UAE MOHAP regulatory and e-services requirements.
Establish processes and controls to maintain accurate and current international regulatory records, registrations, commitments, and submissions.
Monitor international regulatory commitments and ensure timely execution of required post-approval or post-registration activities.

Physical Demands and Work Environment:

Leadership role with a broad, global scope and strategic impact, and opportunity to grow.
Requires flexibility to operate across multiple time zones and respond to urgent global regulatory needs.
Domestic and international travel required for regulatory negotiations, industry representation, and leadership responsibilities.
As the organization evolves, the employee must be adaptable to taking on additional responsibilities, new technologies, or cross-functional projects to meet changing business needs.

The expected, full-time, annual base pay scale for this position in the US is $169K - $242K. Actual base pay will consider skills, experience, and location.

At GRAIL, we believe in recognizing and rewarding the contributions our employees make to our mission and success. In addition to base pay, this role may be eligible for additional compensation, including an annual bonus and/or other incentives, in accordance with applicable plans and the company's discretion. The posted range reflects our good-faith estimate of the base pay we expect to offer for this position at the time of hire. Actual compensation will be determined based on factors such as the candidate’s experience, skills, qualifications, and other relevant considerations.

At GRAIL, we invest in the health, well-being, and future of our employees and their families. Employees in this role are eligible for a comprehensive and competitive benefits package designed to support what matters most, including flexible time off or vacation, a 401(k) retirement plan with employer match, medical, dental, and vision coverage, and thoughtfully selected well-being programs. Benefits are offered in accordance with applicable plans and policies.

GRAIL is an equal employment opportunity employer, and we are committed to building a workplace where every individual can thrive, contribute, and grow. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, disability, status as a protected veteran, or any other class or characteristic protected by applicable federal, state, and local laws. Additionally, GRAIL will consider for employment qualified applicants with arrest and conviction records in a manner consistent with applicable law and provide reasonable accommodations to qualified individuals with disabilities. Please contact us at [email protected] if you require an accommodation to apply for an open position.

GRAIL maintains a drug-free workplace. We welcome job-seekers from all backgrounds to join us!

Responsibilities:

Required Qualifications:

Preferred Qualifications:

Physical Demands and Work Environment:

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