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Manager, United States Regulatory Strategy, Obesity and Related Conditions

United States · Job Posted June 30, 2026
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Job Description

Amgen is seeking a United States Regulatory Lead (USRL) Manager supporting 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. In this product-facing role, you will develop and execute U.S./regional regulatory strategy and tactics under general supervision, 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—with a strong focus on regulatory compliance and patient safety.

Job Responsibility

  • Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT
  • may include GDT/CST/LWG as applicable)
  • Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements
  • Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards
  • Provide content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components)
  • Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent
  • support U.S. labeling negotiation activities
  • Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable)
  • Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback
  • Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks
  • Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations)
  • escalate issues proactively
  • Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance
  • research precedent and history
  • assess and communicate potential impact (including competitor labeling where relevant)
  • Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy
  • Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable)

Requirements

  • Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 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 experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Nice to have

  • 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

What we offer

  • 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
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