Director, Global & International Regulatory Affairs #4810

Responsibilities:

• Define and lead global regulatory strategies for multiple therapeutic areas, product lines, or technology platforms.

• Serve as the company’s senior regulatory representative in global interactions with health authorities, policymakers, and industry forums.

• Lead, inspire, and develop a high-performing regulatory affairs team, including senior managers and associate directors.

• Provide oversight for regulatory submissions, approvals, and lifecycle management across global markets.

• Partner with senior executives and cross-functional leaders to integrate regulatory perspectives into corporate strategy, portfolio prioritization, and business development.

• Anticipate and interpret emerging global regulatory trends, policies, and requirements; shape company strategy and external policy engagement accordingly.

• Ensure compliance with all applicable global regulatory requirements and readiness for audits, inspections, and authority reviews.

• Oversee regulatory contributions to labeling, advertising, and promotional compliance at a global level.

• Drive regulatory innovation, digital transformation, and process improvements to enhance efficiency, quality, and compliance.

• Mentor, coach, and sponsor regulatory leaders, fostering career growth and building a strong succession pipeline.

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:

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field.

• 15+ years of relevant regulatory affairs or related industry experience; Master’s degree 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, EMA, and other agencies.

• Proven track record of developing and leading high-performing teams.

• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:  

• GMP quality management systems (e.g. ISO 13485)

• Risk assessment frameworks (e.g. ISO 14971)

• Clinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)

• Protected health information (e.g. HIPAA, GDPR)

• Regulatory submission of medical devices (e.g. IVDD, IVDR, FDA 21 CFR, UK MDR 2002)

• 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:

• Recognized regulatory expert with broad and deep knowledge of U.S., EU, and global regulatory frameworks.

• 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.

Physical Demands and Working Environment:

• Executive-level role with broad global scope and high visibility.

• Requires availability across time zones and flexibility to meet international submission and authority deadlines.

• Work involves frequent interaction with global health authorities, senior executives, and industry leaders.

• Frequent domestic and international travel required for regulatory meetings, conferences, and leadership engagements.

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!