Director, Technology – Global Regulatory Operations (GRAAS)

Career Category

Information Systems

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director, Technology-Global Regulatory Operations

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead the end-to-end digital strategy, delivery, and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide strategic oversight of the capabilities provided by platforms such as Veeva Vault RIM, Lorenz DocuBridge, and TrialScope, while driving transformational initiatives that improve regulatory operations, data quality, and compliance across all regions and product lifecycles.

The successful candidate will operate at the intersection of technology, compliance, and business process—partnering with senior regulatory leaders, technology partners and external vendors to ensure global systems deliver business value, innovation, and inspection readiness.

Strategic Leadership & Program Ownership

• Lead the global digital strategy and roadmap for regulatory operations across domains such as RIM, CMC/device, labeling, publishing, disclosure, and Promotional Materials compliance.

• Own the lifecycle of regulatory systems from platform selection through implementation, validation, operations, and sunsetting.

• Champion digital transformation initiatives, including automation, data-driven reporting, and the adoption of cloud/AI capabilities to improve submission efficiency and regulatory data management.

• Represent GRAAS IS in audits, inspections, and compliance forums; ensure system audit readiness and alignment with GxP, 21 CFR Part 11, and Amgen’s internal validation policies.

Business Engagement & Customer Partnership

• Collaborate with regulatory business leaders across Oncology, General Medicine, CMC, Device, EU-ICON, JAPAC, R&D Policy, and Promotional Compliance to ensure systems meet evolving global needs.

• Serve as a trusted advisor and change agent, helping business teams align digital investments with strategic regulatory objectives.

• Influence product roadmaps of internal/external vendors and represent Amgen in industry consortia (e.g., Accumulus, TransCelerate).

Operational Excellence & Technical Oversight

• Lead and develop a team of IS professionals managing regulatory systems and services.

• Oversee system validation, configuration management, access controls, and end-user support aligned with ITIL and GAMP 5 frameworks.

• Ensure proactive vendor governance, including contract negotiation, SLA enforcement, and upgrade planning with partners such as Veeva, Lorenz, and TrialScope.

• Utilize SAFe Agile practices to manage enhancements, change controls, testing, release management, and user training.

Must Have Skills:

• Proven experience managing and supporting regulatory information management and submission systems, with hands-on expertise in platforms like Veeva Vault RIM and eCTD publishing tools - Lorenz DocuBridge

• Experience with clinical trial disclosure systems such as TrialScope and TrialAssure

• Deep knowledge of FDA 21 CFR Part 11, GxP validation, and regulatory system compliance best practices

• Experience running multi-region regulatory operations platforms (e.g., PMDA, EMA, FDA, Health Canada)

• Proven leadership and team management skills in cross-functional, matrixed environments, with effective project coordination and on-time delivery.

• Expertise in collaborating with business stakeholders and external vendors, including contract negotiation and performance oversight.

• Hands-on experience with computer system validation processes and documentation, including knowledge of frame