United States Regulatory Manager – Obesity and Related Conditions

Amgen is seeking a United States Regulatory Lead (USRL) Manager to support products in the Obesity and Related Conditions Therapeutic Area. The role will develop and execute U.S./regional regulatory strategy and tactics, represent the region on global teams, and lead U.S. regulatory execution to enable clinical trials and maintain commercial licenses in compliance with local laws, regulations, and Amgen standards.

Requirements

• Doctorate degree
• Regulatory submissions experience and experience interacting with regulatory agencies (FDA)
• Working knowledge of U.S. legislation/regulations relating to medicinal products and applicable regulatory principles
• Understanding of drug development and the U.S. registration pathway (e.g., marketing applications, post-approval changes, extensions/renewals)
• Experience supporting regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas
• Foundational scientific understanding of obesity and metabolic disease, including familiarity with key biological pathways and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers)
• Experience supporting labeling development and cross-functional collaboration (e.g., LWG participation)
• Strong written and oral communication skills; ability to communicate scientific/clinical information clearly
• Ability to anticipate issues, evaluate risks, and contribute to practical contingency planning
• Ability to resolve conflicts, influence without authority, and drive alignment across teams
• Cultural awareness and ability to operate effectively across global/regional teams

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models