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Regulatory Policy and Intelligence - US Director

Amgen

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Location:
United States

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Category:
-

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Contract Type:
Not provided

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Salary:

195466.00 - 230318.00 USD / Year

Job Description:

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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
December 18, 2025

Employment Type:
Fulltime
Work Type:
Remote work
Job Link Share:

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