Associate Vice President

Description:

Reporting to the Vice President of Global Regulatory Affairs (GRA), the Associate Vice President (AVP) of Regulatory Affairs will be responsible for setting strategy and leading the Regulatory Affairs organization for the Pathology/Reagent Partnerships (PT/RP) and Integrated Genomics Divisions (IGD) within Agilent’s Diagnostics & Genomics Group (DGG). S/he will lead a global team of regulatory specialists to establish business strategies providing regulatory guidance and input for regulatory submissions for all new products and modifications to existing products. S/he will lead the execution of regulatory responsibilities, in accordance with global regulatory policy and processes and ensure PT/RP and IGD business units are properly resourced and applicable procedures are in place. S/he will be a member of the GRA leadership team and will periodically travel to support their local teams in delivering business objectives. S/he will also be a member of the DGG Global Quality and Regulatory Affairs (GQRA) leadership team with dotted line reporting to the Vice President of GQRA for DGG.

Role expectations

 Establish regulatory strategies for the PT/RP and IGD divisions with the goal to increase successful and expedient 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. 
 Interact directly with regulatory agencies and lead agency interactions. Lead and develop a team of regulatory affairs professionals in areas such as new product development, labeling reviews, IVD product registrations, and lifecycle support activities. 
 Ensure seamless coordination with internal and external partners to obtain and maintain regulatory approvals for the enablement of product commercialization. 
 Support business and site audits/inspections. 
 Represent the organization at regulatory and business meetings as both an expert and strategic business leader. 
 Prepare, submit, and disseminate periodic reports for DGG internally and to regulatory bodies. 
 Conduct effective and timely regulatory intelligence and research. Monitor current and proposed regulatory issues. Provide risk assessments, options analysis and recommendations for various regulatory scenarios. 
 Lead a team of regulatory affairs professionals, with a focus on talent development, employee engagement and leading diversity, equity, and inclusion (DEI). 
 Provide guidance relative to leading regulatory inspections and appropriately responding to any inquiries / observations. 
 Actively lead departmental resources and budget to meet strategic goals. 
 Create and execute the strategic direction for the PT/RP and IGD Regulatory Affairs organization, and assist in the creation and execution of Agilent’s overall Global Regulatory Affairs strategy. 
 Lead and develop regulatory affairs talent within the Global Regulatory Affairs organization. 
In addition, this individual must ensure that the Global 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 innovative 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. 
 Partners with other members of the Global Regulatory Affairs leadership team to drive forward the strategic direction of the organization. 
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. 
 Familiarity with the markets Agilent serves, Agilent products and customers’ business needs.