Director, Regulatory Affairs - Advertising, Promotional and Labeling #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 [](http://grail.com/) 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 **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: - 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. 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.