Director, Technology Global Regulatory Operations (GRAAS)

Director, Technology-Global Regulatory Operations

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 missionto serve patients living with serious illnessesdrives 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.

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 processpartnering 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

Operational Excellence & Technical Oversight

Must Have Skills

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications :

Preferred Qualifications :

Good-to-Have Skills :

Soft Skills & Leadership Traits :

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work / life balance, and career development opportunities that may include :

Apply now and make a lasting impact with the Amgen team.