JOB DESCRIPTION

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Associate Vice President (AVP) of Diagnostics Regulatory Affairs will be responsible for setting regulatory strategy and providing oversight for diverse portfolios including pathology, companion diagnostics, genomics, and cell and biomolecular analysis products. S/he will lead a team of regulatory professionals based in the US and EU to oversee the planning and execution of regulatory responsibilities, in accordance with global regulatory policy and processes, and ensure teams are properly resourced with applicable procedures and training in place. S/he will be a key member of the GRA leadership team and will also represent GRA in leadership meetings for the Clinical Diagnostics Division (CDD) and the Cell and Molecular Bioanalysis Division (CBD).

QUALIFICATIONS

• Bachelor’s degree in a Life Sciences discipline. Advanced degree highly desirable.
• Minimum of 8 years of Regulatory Affairs leadership roles of increasing responsibility.
• Minimum of 3 years of in vitro diagnostic (IVD) experience with experience in higher classification submissions preferred, i.e. US PMA devices.
• Familiarity with the markets Agilent serves, Agilent products and customers’ business needs
• Experience driving global, transformational initiatives to include establishing effective operating models for regulatory organizations.
• 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.

QUALIFICATIONS

• Bachelor’s degree in a Life Sciences discipline. Advanced degree highly desirable.
• Minimum of 8 years of Regulatory Affairs leadership roles of increasing responsibility.
• Minimum of 3 years of in vitro diagnostic (IVD) experience with experience in higher classification submissions preferred, i.e. US PMA devices.
• Familiarity with the markets Agilent serves, Agilent products and customers’ business needs
• Experience driving global, transformational initiatives to include establishing effective operating models for regulatory organizations.
• 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.

• Establish regulatory strategies with the goal to maximize successful and expeditious product registrations in worldwide jurisdictions. S/he will partner with commercial leaders to define regulatory strategies that support new market access objectives and the launch of new product innovations.
• Direct submission of information to regulatory bodies, including the FDA, notified bodies, and other regulatory authorities across the globe. Ensure that regulatory submissions are complete, organized, of high quality, and compliant with applicable regional regulations.
• Oversee interactions with regulatory agencies and attend meetings with FDA.
• Lead and develop a team of regulatory affairs professionals in areas such as new product development, labeling reviews, IVD product registrations, and product lifecycle support activities.
• Ensure seamless coordination with internal and external partners to obtain and maintain regulatory approvals for the enablement of product commercialization.
• Serve as a senior management contact to pharma partners for CDx co-development programs.
• Support business and site audits/inspections.
• Represent the organization at regulatory and business meetings as both an expert and strategic business leader.
• Conduct effective and timely regulatory intelligence. Monitor current and proposed regulatory issues. Provide risk assessments, options analysis and recommendations for various regulatory scenarios.
• Offer mentorship to regulatory team members, with a focus on talent development and employee engagement.
• Provide guidance relative to managing regulatory inspections and appropriately responding to any inquiries / observations.
• Actively manage departmental resources and budget to meet strategic goals.
• Create and execute the strategic direction for the Diagnostics Regulatory Affairs team.

In addition, this leader must work closely with the GRA leadership team to ensure the Diagnostics Regulatory Affairs team:

• Integrates seamlessly into the broader GRA organization and demonstrates core values, including integrity and accountability.
• Communicates with internal and external stakeholders in an accurate, complete, and timely manner.
• Directs and contributes to initiatives within GRA and the broader Global Quality and Regulatory Affairs (GQRA) organization.
• Applies knowledge of regulatory frameworks/solutions and external environments throughout the product lifecycle.
• Applies knowledge of research and development, design controls, analytical and clinical validation steps, and related regulations in IVD and medical device development to broader GQRA procedures and initiatives.
• 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 IVDs and 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.
• Partners with other members of the Global Regulatory Affairs leadership team to drive forward the strategic direction of the organization.