Vice President, Regulatory Affairs

Vice President, Regulatory Affairs – ELMAC

In this vital role as Vice President, Regulatory Affairs for 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.

What you will do

• Define and drive a cohesive regulatory strategy across ELMAC that aligns with global priorities and enables timely, efficient product development and market access.
• Build and lead a modern regulatory organization equipped to meet future demands, including establishing a clear vision, operating model, and workforce strategy.
• Serve as a strategic advisor to senior leadership, providing clear visibility into risks, trade‑offs, and opportunities, and ensuring regulatory considerations are embedded early in development and commercialization strategies.
• Partner closely with country leadership to ensure regulatory strategies enable local business objectives and patient access, focusing on key markets and growth regions.
• Champion new ways of working across Regulatory Affairs, including automation, advanced analytics, and the use of emerging technologies, to improve speed, quality, and scalability of regulatory processes while reducing complexity and cost.
• Ensure consistent, high‑quality regulatory submissions and labeling practices across the region, establishing clear performance metrics and continuously improving processes.
• Represent the organization with global and regional health authorities, industry groups, and policy forums, building strong external relationships that enhance credibility and influence regulatory policy.
• Anticipate and help lead the evolution of Regulatory Affairs, including increased use of real‑world evidence, digital data exchange, and global regulatory collaboration, positioning the organization for a more connected, data‑driven, and technology‑enabled environment.

What we expect of you

• 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

• 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.

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.

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