Regulatory Policy and Intelligence - US Director

Role Summary

Regulatory Policy and Intelligence - US Director leads the development and articulation of Amgen's positions on regulatory policies impacting Amgen's business and serves as the U.S. Policy Lead for Global Regulatory Policy and Intelligence. The role engages regulators, industry groups, and stakeholders to advance policy issues aligned with Amgen's goals and priorities.

Responsibilities

• Master a range of regulatory policy topics and provide strategic U.S. regulatory policy advice and guidance related to Amgen’s product portfolio, including AI and emerging regulatory technologies (e.g., cloud-based submissions).
• Engage US regulatory authorities, industry, and professional associations at the policy level.
• Leverage relationships with FDA staff and industry/trade association colleagues to advance Amgen's regulatory policy position.
• 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 policy development and implementation.
• Lead the development and execution of strategic plans for assigned policy areas, including topics such as CMC, Precision Medicine, and Combination Products.
• Ensure Amgen's regulatory policy positions are represented to inform policy development and implementation.
• Foster a reputation with regulators as science-based, reliable, and trustworthy by advocating sound policies.
• Provide internal stakeholders with a strategic regulatory policy perspective.
• Assist senior leadership in selecting issues, establishing priorities, and developing regulatory policy advocacy plans.
• Help create infrastructure/processes for developing the regulatory policy and intelligence function.

Qualifications

• Required: Doctorate degree and 4 years of related experience; Or Master’s degree and 7 years of related experience; Or Bachelor’s degree and 9 years of related experience.