--- title: 'Director/ Associate Director, International Regulatory Affairs #4809 at GRAIL' canonical: 'https://feeny.ai/job/director-associate-director-international-regulatory-affairs-4809-grail-7xm7ycajd3sr' type: 'job' last_seen: '2026-09-07' --- # Director/ Associate Director, International Regulatory Affairs #4809 at GRAIL - **Company:** GRAIL - **Location:** Sunnyvale, CA - **Employment:** full-time - **Work type:** remote - **Posted:** 2026-08-14 - **Last confirmed live:** 2026-09-07 - **Apply:** https://jobs.lever.co/grailbio/ed57b7a1-95a2-45d1-b488-5547fe5d65d7 ## Job description 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 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. ## About GRAIL ## Company Overview - **One-liner**: GRAIL develops a multi-cancer early detection blood test (Galleri) that screens for many of the deadliest cancer types before symptoms appear. - **Entity Type**: Public (ticker: GRAL on Nasdaq Global Select Market) - **Headquarters**: Menlo Park, California, USA - **Founded**: Not publicly available from provided sources - **Founders**: Not publicly available from provided sources ## Core Business - Primary industry: Healthcare diagnostics / biotechnology - Target customers: B2B (health systems, employers, insurers) and B2C (individuals aged 50+ with elevated cancer risk) - Mission: "To detect cancer early, when it can be cured." ## Products & Services - **[Galleri® Test]**: A multi-cancer early detection (MCED) blood test that uses next-generation sequencing, machine learning, and a proprietary methylation platform to identify cancer signals and predict the tissue of origin. Available by prescription in the U.S. as a CLIA-certified, CAP-accredited laboratory-developed test (not yet FDA cleared). ## Market Standing - **Valuation/Market Cap**: Not publicly available from provided sources (publicly traded; market cap fluctuates) - **Key Metric**: Over 250,000 Galleri tests commercially delivered as of November 2024; >380,000 participants enrolled across clinical studies; >300 scientific publications and presentations - **Notable Investors/Partners**: Providence, Quest Diagnostics, athenahealth, Samsung, AstraZeneca, BeniComp, Curative Insurance Company - **Growth Signals**: Private placement financing of $325 million (October 2025); first healthcare system (Providence) to offer Galleri; collaboration with Samsung for Asia expansion; REACH study enrolling diverse Medicare populations; long-term data from NHS-Galleri trial and PATHFINDER 2 study showing >7-fold increase in cancer detection when added to standard screenings ## Competitive Advantages - First-of-its-kind multi-cancer early detection test that screens for cancers without recommended screening tests - Proprietary methylation-based platform combined with machine learning and large-scale clinical data - Extensive clinical program with >380,000 participants and >300 publications - CAP-accredited, CLIA-certified lab facilities with >170,000 square feet and capacity for multi-year growth - Strong IP portfolio and regulatory experience ## Strategic Focus - Scaling commercial access through health system partnerships, employer/insurer benefits, and digital ordering platforms - Expanding clinical evidence for diverse populations (REACH study, veterans) - International expansion (e.g., Asia via Samsung collaboration) - Building operational foundation as an independent public company post-Illumina spin-off - Advancing next-generation platform and risk classification tests (e.g., lung cancer study with AstraZeneca) ## Why Work Here - Mission-driven culture focused on solving a high-impact problem (early cancer detection) - Recognized as a 2025 Best Place to Work by Built In and BioSpace; Fortune Change the World list (2023) - Multidisciplinary team spanning biotech, genomics, data science, clinical development, and commercial operations - Benefits include competitive salaries, comprehensive health coverage (medical, dental, vision), and flexible time off - Emphasis on collaboration, agility, courage, and data-driven decision-making - Remote/hybrid policy not specified in provided sources; office locations include Menlo Park, CA ## Sources 1. [grail.com/careers](https://grail.com/careers/) 2. [grail.com](https://grail.com/) 3. [grail.com/about-us](https://grail.com/about-us/) 4. [jobs.lever.co/grailbio](https://jobs.lever.co/grailbio) 5. [investors.grail.com (SEC Filing)](https://investors.grail.com/static-files/6f7d7c6d-1d22-4045-a6b3-bf4893548649) ## Other roles at GRAIL - [GRAIL Galleri Consultant 1 (Fort Lauderdale) #4947](https://feeny.ai/job/grail-galleri-consultant-1-fort-lauderdale-4947-grail-fort-lauderdale-gzq8drbf80gk) — Fort Lauderdale, FL - [Data Engineer 1, Operational Technology - Operations #4941](https://feeny.ai/job/data-engineer-1-operational-technology-operations-4941-grail-durham-ptks220z9cmw) — Durham, NC - [Head of Employment Law and Litigation #4939](https://feeny.ai/job/head-of-employment-law-and-litigation-4939-grail-sunnyvale-jz799ffzf11k) — Sunnyvale, CA - [Health System Partnerships Associate Director # 4932 (Eastern U.S.)](https://feeny.ai/job/health-system-partnerships-associate-director-4932-eastern-u-s-grail-united-0jyba15gt6kr) — United States - [Health System Partnerships Associate Director # 4931 (Western U.S.)](https://feeny.ai/job/health-system-partnerships-associate-director-4931-western-u-s-grail-united-k6hahc9fstxg) — United States - [Senior Scientist, Operations Investigation Team (OIT) #4936](https://feeny.ai/job/senior-scientist-operations-investigation-team-oit-4936-grail-durham-zcz4f510fq9y) — Durham, NC - [Senior Corporate Counsel, Compliance (Healthcare) #4927](https://feeny.ai/job/senior-corporate-counsel-compliance-healthcare-4927-grail-sunnyvale-tgkznfat42w8) — Sunnyvale, CA - [Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810](https://feeny.ai/job/director-regulatory-affairs-advertising-promotional-and-labeling-4810-grail-0sy0qr0b6srt) — Sunnyvale, CA - [Vice President, People #4921](https://feeny.ai/job/vice-president-people-4921-grail-sunnyvale-dzh8jcbr40e3) — Sunnyvale, CA - [Billing Operations Analyst (Healthcare Billing) #4556](https://feeny.ai/job/billing-operations-analyst-healthcare-billing-4556-grail-raleigh-qdnzgkyzcggk) — Raleigh, NC / Durham, NC