Vice President, Regulatory Affairs – ELMAC

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, data-driven, and technology-enabled regulatory environment.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

• Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
• Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
• Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
• Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Basic Qualifications:

• Doctorate degree & 8 years of directly related experience OR
• Master’s degree & 10 years of directly related experience OR
• Bachelor’s degree & 12 years of directly related experience AND
• 8 years of direct managerial experience. Previous experience managing other managers

Preferred Qualifications:

• Advanced degrees (e.g., Ph.D. or PharmD) preferred
• A minimum of eight years of industry experience, including direct leadership of highly skilled teams composed of senior professionals.
• Extensive knowledge of regulatory requirements and strategies in relevant therapeutic areas.
• Regulatory Leadership in a Matrix Organization: Proven ability to lead, manage, and inspire teams within a complex, multi-functional, multi-national matrix structure.
• Regional Regulatory and Healthcare Ecosystem Expertise: Experience navigating regional, and local regulatory landscapes and healthcare systems.
• Strategic External Engagement: Strong ability to engage with regulatory authorities, industry bodies, and key external stakeholders, with an established network within the regulatory community.
• Pharmaceutical Industry and Compliance Expertise: Strong understanding of the pharmaceutical industry, including legal, ethical, and health system considerations impacting regulatory decisions.
• Financial and Resource Management: Experience in budgeting, resource allocation, and operational efficiency within regulatory functions.
• Effective Communication and Problem Solving: Skilled in articulating complex regulatory and scientific concepts in both written and verbal formats, with a track record of sound decision-making and strategic problem-solving.

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.
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:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
  

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.