Vice President, Regulatory Affairs – ELMAC

Career Category

Regulatory

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Vice President, Regulatory Affairs – ELMAC

What you will do

Let’s do this. Let’s change the world. In this vital role as Vice President, Regulatory Affairs ELMAC, (Europe, Latin America, Middle East, Africa & Canada) you will set the strategic direction for Regulatory Affairs across ELMAC, ensuring the organization delivers compliant, innovative, and forward-looking regulatory strategies that accelerate patient access and support enterprise growth. You will operate as a key member of the global regulatory leadership team, shaping both regional execution and the future of the regulatory function. This role defines and drives the regional regulatory strategy, shaping submissions, health authority engagement, and portfolio execution to enable compliant development, accelerate patient access, and support enterprise growth.

Set and lead the regional regulatory strategy
Define and drive a cohesive regulatory strategy across ELMAC that aligns with global priorities and enables timely, efficient product development and market access. Ensure regional strategies are integrated, forward-looking, and responsive to an evolving regulatory landscape.

Lead and evolve a high-performing organization
Build and lead a modern regulatory organization equipped to meet future demands. Establish a clear vision, operating model, and workforce strategy. Drive strong engagement, develop leadership bench strength, and ensure effective resource allocation and prioritization across the region.

Drive enterprise alignment and decision-making
Serve as a strategic advisor to senior leadership, providing clear visibility into risks, tradeoffs, and opportunities. Influence enterprise decisions by connecting regional insights with global priorities and ensuring regulatory considerations are embedded early in development and commercialization strategies.

Enable affiliate and market success
Partner closely with country leadership to ensure regulatory strategies enable local business objectives and patient access. Strengthen alignment between regional priorities and affiliate execution, with particular focus on key markets and growth regions.

Accelerate innovation and transformation
Champion new ways of working across Regulatory Affairs, including automation, advanced analytics, and the use of emerging technologies. Lead initiatives that improve speed, quality, and scalability of regulatory processes while reducing complexity and cost.

Strengthen quality and operational excellence
Ensure consistent, high-quality regulatory submissions and labeling practices across the region. Establish clear performance metrics and continuously improve processes to enhance reliability, compliance, and efficiency.

Shape the external regulatory environment
Represent the organization with global and regional health authorities, industry groups, and policy forums. Build strong external relationships that enhance credibility, influence regulatory policy, and enable more predictable and efficient pathways for product approval and access.

Define the future of the regulatory function
Anticipate and help lead the evolution of Regulatory Affairs, including increased use of real-world evidence, digital data exchange, and global regulatory collaboration. Position the organization to lead in a more connected, >

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