U.S. Regulatory Strategy – Obesity and Related Conditions, Senior Manager

About the role

Join Amgen’s Mission of Serving Patients. In this vital role, you will support products in the Obesity and Related Conditions Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This role requires demonstrated experience leading U.S. regulatory strategy and FDA interactions and may be performed within a global regulatory organization supporting U.S. regulatory responsibilities.

Responsibilities

• Contribute to the development and refinement of global regulatory strategy in partnership with the GRL, providing U.S.-specific insights on regulatory precedent, risk, and Health Authority expectations in obesity and related metabolic conditions.
• Apply scientific expertise in obesity and metabolic disease to inform regulatory strategy, including clinical endpoints and long-term safety considerations.
• Partner with the GRL and key market leads to align on global development timelines, core documents (e.g., protocols, IBs, KDEs), and regulatory positioning.
• Execute the U.S. regulatory strategy for assigned programs and represent the region on global governance teams.
• Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements.
• Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy.
• Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group, including negotiation approach, timelines, and deviation/waiver decisions.
• Provide strategic input on U.S. development pathways (e.g., expedited programs, orphan designation, pediatric strategy), informed by the evolving regulatory landscape.
• Lead Health Authority interactions for assigned products, including preparing and leading engagements and communicating outcomes to the GRT and senior management.
• Manage responses to agency questions (RTQs) and feedback by coordinating cross-functional input and ensuring timely, high-quality submissions.
• Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management.
• Ensure ongoing compliance for assigned products (e.g., commitments, obligations, regulatory records) and proactively escalate issues.
• Monitor and apply U.S. regulatory intelligence, including evolving legislation, guidance, and relevant competitor activity.
• Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure aligned strategy and support U.S. data and promotional considerations.
• Lead and develop staff, where applicable, through prioritization, coaching, and resource planning to deliver on program objectives.

Qualifications

• Doctorate degree and 2 years of directly related experience
• OR Master’s degree and 6 years of directly related experience
• OR Bachelor’s degree and 8 years of directly related experience
• OR Associate’s degree and 10 years of directly related experience
• OR High school diploma / GED and 12 years of directly related experience
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above