Vice President, Global Regulatory Affairs

Agilent Technologies; Maryland; Remote; USD 244,000 - 382,000; Full time

Job summary

An established industry player seeks a Vice President of Global Regulatory Affairs to lead and innovate in regulatory strategy. This pivotal role involves managing submissions to regulatory bodies, ensuring product compliance, and guiding a talented regulatory affairs team. The ideal candidate will possess extensive experience in regulatory leadership, particularly in in vitro diagnostics, and will thrive in a dynamic environment. With remote work options and a competitive salary, this position offers a unique opportunity to make a significant impact in the life sciences sector.

Qualifications

• 10+ years in regulatory leadership roles, preferably in in vitro diagnostics.
• Familiarity with international environmental and biologics regulations.

Responsibilities

• Lead the development of regulatory strategies for product registrations.
• Manage submissions to regulatory bodies like the FDA and EMA.
• Guide regulatory inspections and responses.

Skills

Regulatory Strategy Development

Regulatory Submissions Management

Regulatory Intelligence and Research

Stakeholder Communication

Team Leadership

Education

Bachelor's degree in Life Sciences

Advanced degree

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 answers and insights to improve the world around us. More information about Agilent is available at www.agilent.com.

Position Overview

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. This role oversees ensuring a robust regulatory affairs function aligned with regulatory and ISO requirements, focused on enabling new product introductions, and maintaining governance processes across Agilent.

This individual will be a key member of the GQRA executive leadership team, working closely to refine and execute the multi-year strategic roadmap.

Role Expectations

1. Lead the development of regulatory strategies for successful product registrations worldwide.
2. Manage submissions to regulatory bodies such as the FDA, EMA, ensuring completeness, quality, and compliance.
3. Interact directly with regulatory agencies and manage these relationships.
4. Conduct regulatory intelligence and research, monitor issues, and provide risk assessments.
5. Represent the organization at regulatory and compliance meetings as an expert and strategic leader.
6. Prepare, submit, and disseminate reports internally and to regulatory bodies.
7. Provide oversight to ensure product compliance and quality.
8. Guide regulatory inspections and responses.
9. Identify key regulatory issues and trends, developing action plans.
10. Lead and develop the regulatory affairs team.
11. Optimize processes and procedures for efficiency and growth.
12. Manage departmental resources and budgets.

Additional Responsibilities

• Embed core values, integrity, and accountability within the team.
• Ensure effective communication with stakeholders.
• Contribute to initiatives and develop good regulatory practices.
• Apply knowledge of regulatory frameworks throughout the product lifecycle.
• Utilize scientific and regulatory knowledge to improve development and oversight of medical devices.
• Leverage systems to operate the regulatory function effectively.
• Maintain requirements for product market presence, including reporting.
• Provide strategic advice throughout product development and lifecycle management.

Qualifications

• Bachelor's degree in Life Sciences; advanced degree preferred.
• Over 10 years in regulatory leadership roles, preferably in in vitro diagnostics.
• Familiarity with international environmental, chemical, and biologics regulations is desirable.
• Experience with global strategic initiatives and leading multicultural teams.

Personal Characteristics

• Transformational, passionate, and visionary leadership qualities.
• High emotional intelligence and creativity.
• Resilient, adaptable, and excellent communicator.
• Customer-focused with strong influencing skills.
• Willing to travel approximately 35% globally.

Additional Details

This is a full-time position with remote work options, offering a salary range of $244,000 to $381,250 annually plus bonuses, stock, and benefits. Applications are accepted until April 15, 2025, or until filled. For more information, visit https://careers.agilent.com/locations. Agilent is an Equal Opportunity Employer committed to diversity and inclusion.