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Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen’s goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence.
Job Responsibility:
Master a range of regulatory policy topics and provide strategic U.S. regulatory policy advice and guidance related to Amgen’s product portfolio, including a focus on artificial intelligence and emerging regulatory technologies
Engage US regulatory authorities, industry, and professional associations at the policy level
Leverage key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy
Coordinate the implementation of new U.S. regulatory policy and guidance across Amgen functions
Engage cross-functional teams to develop strategic/long-term plans for the development and implementation of policies
Master a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products
Lead the development and execution of strategic plans for each assigned policy area
Ensure that Amgen's regulatory policy positions are successfully represented to inform policy development and implementation
Foster a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies
Provide internal stakeholders with a strategic regulatory policy perspective
Assist and advise senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Assist in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function
Requirements:
Doctorate degree and 4 years of related experience
Master’s degree and 7 years of related experience
Bachelor’s degree and 9 years of related experience
Deep knowledge and understanding of the U.S. regulatory environment
Ability to provide insights to internal stakeholders
Ability to shape the external regulatory environment to support Amgen priorities
What we offer:
Total Rewards Plan
Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
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
Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
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