Director, Regulatory Affairs - Advertising, Promotional and Labeling #4810

grailbio · Sunnyvale, CA · 1 month ago

Work mode: Hybrid
Employment: Contract
Category: Legal
Experience: 8+ years

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, 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.

The expected, full-time, annual base pay scale for this position is $189K - $271K. 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:

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