Job Description

Agilent inspires and supports discoveries that advance quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.

Reporting to the Senior Vice President, Chief Quality and Regulatory Officer, the Vice President of Global Regulatory Affairs will be responsible for setting strategy and leading the Global Regulatory Affairs organization for Agilent.  S/he will have oversight for ensuring that Agilent’s Regulatory Affairs Function is robust, well-connected to Agilent’s businesses, focused on enabling new product introductions, and will establish and maintain governance processes for regulatory affairs across Agilent, all in alignment with regulatory and ISO requirements. 

 

S/he will be a key member of the GQRA executive leadership team and will work in close partnership with the GQRA leaders to refine and execute the multi-year GQRA strategic roadmap. 

 

Role expectations 

Lead the development of regulatory strategies designed to maximize successful and expedient product registrations in worldwide jurisdictions. 

Direct submission of information to regulatory bodies, including the FDA, EMA, and other regulatory authorities across the globe.   Ensure that regulatory submissions are complete, organized, of high quality, and compliant with applicable regional regulations.

Interact directly with regulatory agencies; manages agency interactions. 

Conduct effective and timely regulatory intelligence and research. Monitor current and proposed regulatory issues. Provide risk assessments and recommendations for various regulatory scenarios. 

Represent the organization at regulatory and compliance meetings as both an expert and strategic business leader.

Prepare, submit, and disseminate periodic reports internally and to regulatory bodies. 

Provide strategic and technical oversight to promote the compliance and quality of all products manufactured and distributed by Agilent. 

Provide guidance relative to managing regulatory inspections and appropriately responding to any inquiries / observations. 

Identify key regulatory issues and trends for senior management and proactively develop and deploy the necessary action plans. 

Lead a team of regulatory affairs professionals, with a focus on talent development and employee engagement. 

Contribute to the optimization and implementation of processes and procedures, including developing process documents and identifying solutions for process optimization and efficiency commensurate with departmental growth. 

Actively manage departmental resources and budget to meet strategic goals. 

In addition, this individual must ensure that the Regulatory Affairs team as a whole: 

Integrates and demonstrates core values, integrity, and accountability.

Communicates with internal and external stakeholders in an accurate, complete, and timely manner. 

Directs and contributes to initiatives within the organization, with groups engaged in developing good regulatory practice. 

Applies knowledge of regulatory frameworks/solutions and external environments throughout the product lifecycle. 

Applies knowledge of the research and development, preclinical and clinical steps, and related regulations in medical device development. 

Understands and applies evolving basic and translational science, regulatory science, and public health concepts to drive new approaches to improve the development, review, and oversight of medical devices. 

Leverages systems and processes to successfully operate a regulatory function.

Demonstrates knowledge of requirements and processes to maintain product on the market, including reporting and surveillance. 

Provides strategic and technical advice throughout product life cycle, making an important contribution both commercially and scientifically to the success of a development program. 

Qualifications

Bachelor’s degree in a Life Sciences discipline. Advanced degree highly desirable. 

Minimum of (10+) years of Regulatory Assurance leadership roles of increasing responsibility with a multi-national company.  In vitro diagnostic experience in required. 

Familiarity with international environmental, chemical, and biologics requirements is highly desirable. 

Familiarity with the markets Agilent serves, Agilent products and customers’ business needs.

Experience driving global, transformational initiatives including creating complex business strategies & multi-year actionable plans. 

Demonstrated track record of results using interpersonal, relationship-building skills required to lead multi-cultural and geographically dispersed teams in a fast-paced, highly matrixed environment. 

Personal Characteristics 

Transformational leader who brings intensity & excitement every day.

Passionate, visionary thinker with a desire to excel and inspire others.

High degree of self-awareness and emotional intelligence. 

Creative thinker willing to explore unique, out-of-the-box solutions.

Persistent in the face of resistance and adaptable to rapid change. 

Ability to weave complex concepts into a clear compelling message. 

Excellent collaboration, influencing and facilitation skills across business groups, functions and employee levels.

Pragmatic and customer focused.

Ability to identify and focus on key priorities.

Self-starter, self-reliant, courage of conviction.

Willingness to travel globally on a regular basis. 

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Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 18, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $244,000.00 - $381,250.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required: 35% of the Time

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory