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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.
Job Responsibility:
Set and lead the regional regulatory strategy
Lead and evolve a high-performing organization
Drive enterprise alignment and decision-making
Enable affiliate and market success
Accelerate innovation and transformation
Strengthen quality and operational excellence
Shape the external regulatory environment
Define the future of the regulatory function
Requirements:
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
8 years of direct managerial experience
Previous experience managing other managers
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
Nice to have:
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 we offer:
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