Vice President, Regulatory Affairs – ELMAC
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.
Responsibilities
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.
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 enterprise alignment and decision‑making – Serve as a strategic advisor to senior leadership, providing clear visibility into risks, tradeoffs, and opportunities.
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 the use of emerging technologies.
Strengthen quality and operational excellence – Ensure consistent, high‑quality regulatory submissions and labeling practices across the region and continuously improve processes.
Shape the external regulatory environment – Represent the organization with global and regional health authorities, industry groups, and policy forums.
Define the future of the regulatory function – Anticipate and help lead the evolution of Regulatory Affairs, including increased use of real‑world evidence and global regulatory collaboration.
What We Expect Of You
* Experience leading regulatory strategy across multiple regions.
* Strong track record of building and developing high‑performing teams.
* Deep understanding of regulatory requirements in Oncology, Inflammation, General Medicine, and Rare Disease therapeutic areas.
* Demonstrated ability to influence senior leadership and shape enterprise strategy.
* Top‑tier academic credentials and at least 8 years of industry experience.
Leadership Attributes
* Inspire – Create a connected, inclusive, and inspiring work environment.
* Accelerate – Enable speed that matches the urgency of patient needs.
* Integrate – Connect the dots to amplify collective power and drive results.
* Adapt – Lead through change by defining clear courses of action.
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, including managing other managers.
Preferred Qualifications
* Advanced degrees (e.g., Ph.D. or PharmD).
* Extensive knowledge of regulatory requirements and strategies in relevant therapeutic areas.
* Proven ability to lead in a complex, multi‑functional, multi‑national matrix organization.
* Regional regulatory and healthcare ecosystem expertise with strong engagement of local authorities.
* Strategic external engagement and established network within the regulatory community.
* Strong understanding of pharmaceutical industry compliance, legal, and ethical considerations.
* Experience in budgeting, resource allocation, and operational efficiency within regulatory functions.
* Effective communication and problem‑solving skills with a track record of sound decision‑making.
What You Can Expect Of Us
Amgen offers a Total Rewards Plan, based on eligibility, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save toward retirement or other goals, work/life balance, and career development opportunities, including:
* Comprehensive employee benefits package – 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 sales‑based incentive plan for field sales).
* 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.
Equal Opportunity Employer
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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