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

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.

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!