Vice President, Regulatory Affairs – ELMAC
In this vital role, you will set the strategic direction for Regulatory Affairs across ELMAC (Europe, Latin America, Middle East, Africa & Canada). You will operate as a key member of the global regulatory leadership team, shaping both regional execution and the future of the regulatory function. Your focus will be on accelerating patient access, supporting enterprise growth, and ensuring compliant development. Responsibilities
Set and lead the regional regulatory strategy:
Define and drive a cohesive regulatory strategy across ELMAC that aligns with global priorities. Ensure strategies are integrated, forward‑looking, and responsive to an evolving regulatory landscape.
Build and lead a modern regulatory organization:
Establish a clear vision, operating model, and workforce strategy. Drive strong engagement, develop leadership bench strength, and ensure effective resource allocation.
Drive enterprise alignment and decision‑making:
Serve as a strategic advisor to senior leadership, providing clear visibility into risks, trade‑offs, and opportunities. Influence enterprise decisions by connecting regional insights with global priorities.
Enable affiliate and market success:
Partner closely with country leadership to ensure regulatory strategies enable local business objectives and patient access.
Accelerate innovation and transformation:
Champion new ways of working across Regulatory Affairs, including automation, advanced analytics, and emerging technologies. Lead initiatives that improve speed, quality, and scalability of regulatory processes.
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 to enhance credibility, influence regulatory policy, and enable efficient product approval.
Define the future of the regulatory function:
Anticipate and lead the evolution of Regulatory Affairs, including increased use of real‑world evidence, digital data exchange, and global collaboration.
Qualifications
Basic Qualifications:
Doctorate degree & 8 years of directly related experience Master’s degree & 10 years of directly related experience Bachelor’s degree & 12 years of directly related experience AND 8 years of direct managerial experience
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. Proven ability to lead, manage, and inspire teams within a complex, multi‑functional, multi‑national matrix structure. Experience navigating regional and local regulatory landscapes and healthcare systems. Strong ability to engage with regulatory authorities, industry bodies, and key external stakeholders, with an established network within the regulatory community. Strong understanding of the pharmaceutical industry, including legal, ethical, and health system considerations impacting regulatory decisions. Experience in budgeting, resource allocation, and operational efficiency within regulatory functions. Skilled in articulating complex regulatory and scientific concepts in written and verbal formats, with a track record of sound decision‑making and strategic problem‑solving.
EEO Statement
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.
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