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The Director, Regulatory Affairs - Advertising, Promotional and Labeling provides strategic leadership and operational compliance for the company’s product messaging. The Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. This role will also partner with executive leadership to guide regulatory strategy for GRAIL’s portfolio and drive business critical decisions.
This is a hybrid role based in Sunnyvale, CA. Our current flexible work arrangement policy 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:
Provide cross-functional leadership and representation for Regulatory Affairs on the Promotional Materials Review Committee, ensuring all promotional materials are compliant with regulatory requirements while shaping and aligning with overarching corporate and portfolio strategies
Experience leading or supporting product promotion and launches is preferred.
Define and shape innovative, compliant regulatory strategies and solutions for highly complex and business-critical promotional concepts, enabling business objectives while proactively mitigating regulatory risk across the portfolio
Lead the oversight and evaluation of product claims to ensure scientifically robust and compliant messaging
Establish and advance the strategic framework for the advertising and promotion process through developing SOPs to drive continuous improvement, governance, and operational compliance across the organization
Influence and drive alignment with senior leadership, building consensus and shaping decisions to balance business objectives with regulatory requirements
Demonstrated ability to lead and foster a culture of continuous learning and process improvement across the organization
Exceptional communication and influencing skills
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
Taking on additional responsibilities.
Participating in cross functional projects and initiatives.
Adapting to new technologies, processes, or methodologies.
Supporting other departments or teams during periods of high demand.
Contributing to special projects or temporary assignments as needed.
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:
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:
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 8+ years
Prior regulatory affairs experience in medical devices, clinical laboratory and/or diagnostics
Proven record of success leading cross-functional teams to resolve highly complex promotional regulatory challenges, driving innovative, compliant solutions across the portfolio
Demonstrated level of knowledge of global regulations, guidances, and standards, particularly around advertising and promotion
Preferred Qualifications:
- Exceptional leadership skills, with the ability to inspire, align, and influence at all organizational levels.
Strong strategic foresight with the ability to anticipate regulatory and policy shifts and align company direction.
Excellent communication, negotiation, and executive presentation skills.
Proven ability to lead complex programs and drive portfolio-level decision-making.
Advanced proficiency with regulatory systems, submission tools (e.g., eCTD), and enterprise compliance platforms.
Commitment to developing talent and building long-term organizational capability.
This role may be eligible for other forms of compensation, including an annual bonus and/or incentives, subject to the terms of the applicable plans and Company discretion. This range reflects a good-faith estimate of the range that the Company reasonably expects to pay for the position upon hire; the actual compensation offered may vary depending on factors such as the candidate’s qualifications. Employees in this role are also eligible for GRAIL’s comprehensive and competitive benefits package, offered in accordance with our applicable plans and policies. This package currently includes flexible time-off or vacation; a 401(k) retirement plan with employer match; medical, dental, and vision coverage; and carefully selected mindfulness programs.
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!
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Skills Required
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field
- 15+ years of relevant regulatory affairs or related industry experience (Master's with 13+ years or PhD with 10+ years)
- Demonstrated success leading regulatory strategy across multiple portfolios and therapeutic areas
- Extensive experience interacting with global regulatory authorities, including FDA and EMA
- Proven track record of developing and leading high-performing teams
- Knowledge of GMP quality management systems (e.g., ISO 13485)
- Knowledge of risk assessment frameworks (e.g., ISO 14971)
- Knowledge of clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
- Knowledge of protected health information requirements (e.g., HIPAA, GDPR)
- Knowledge of regulatory submission requirements for medical devices and diagnostics (e.g., IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
- Experience with development and operations in regulated clinical study environments (e.g., ICH E6 GCP, ISO 20916, FDA 21 CFR Part 11/Part 50/Part 54/Part 56)
- Recognized regulatory expert with broad knowledge of U.S., EU, and global regulatory frameworks
- Exceptional leadership, executive communication, negotiation, and presentation skills
- Proven ability to lead complex programs and drive portfolio-level decision-making
- Advanced proficiency with regulatory systems and submission tools (e.g., eCTD) and enterprise compliance platforms
- Commitment to developing talent and building long-term organizational capability
What the Team is Saying
GRAIL Compensation & Benefits Highlights
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Healthcare Strength — Health coverage is presented as comprehensive across medical, dental, and vision, with added mental‑health resources and abortion‑travel support noted. These offerings are highlighted across regions with multiple plan options.
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Equity Value & Accessibility — Employees can access new‑hire equity grants that vest over four years and a discounted Employee Stock Purchase Plan, aligning compensation with company performance. Feedback suggests equity and ESPP meaningfully contribute to total rewards.
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Leave & Time Off Breadth — Flexible or “unlimited” time off, paid holidays, and seasonal company breaks are emphasized. Feedback suggests the FTO policy is usable in practice for many teams.
GRAIL Insights
What We Do
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop and commercialize pioneering products.
Why Work With Us
Everything we do is guided by our mission to detect cancer early, when it can be cured. It’s the reason we’re here, and it’s no small task. The right people make all the difference. That’s why we’re looking for those who strive to share their knowledge, contribute their skills, inspire each other and commit to something bigger than themselves.
Gallery
GRAIL Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
GRAIL has a variety of work types depending on the roles. Some roles are onsite like a lab role, some are fully remote like our Galleri Sales Consultant roles. Others are hybrid with 3 days onsite.
