United States Regulatory Lead – Obesity and Related Conditions

• Execute the approved 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, U.S. regulatory requirements, and Amgen standards
• Lead U.S. regulatory document development, including labels, briefing packages, and key submission components consistent with product strategy
• Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group (LWG), including negotiation approach, timelines, and deviation/waiver decisions as applicable
• Provide regulatory direction on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable)
• Lead Health Authority interactions for assigned products: build relationships, prepare/lead engagements, and document/communicate outcomes to GRT and senior management
• Manage Responses to Questions (RTQs) and other agency feedback by coordinating cross-functional inputs, driving alignment, and ensuring timely, high-quality responses
• Assess regulatory risk and likelihood of success
• communicate scenarios, expectations, and contingencies to GRT and line management
• Ensure ongoing regulatory compliance for assigned products (e.g., commitments, obligations, regulatory history/record accuracy) and escalate issues proactively
• Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance and assess/communicate impact (including competitor labeling where relevant)
• Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure strategy alignment, including support for U.S. promotional/data applicability considerations as needed
• If applicable, lead and develop staff through clear prioritization, coaching, and resource planning to meet program objectives

• Doctorate degree and 2 years of directly related experience
• Master’s degree and 6 years of directly related experience
• Bachelor’s degree and 8 years of directly related experience
• Associate’s degree and 10 years of directly related experience
• Regulatory submissions experience and demonstrated experience interacting with regulatory agencies (FDA)
• Strong knowledge of the U.S. regulatory environment and drug development lifecycle
• Experience developing/implementing regulatory strategy, including risk management and contingency planning
• Experience leading U.S. labeling strategy, negotiation, and timeline management in a cross-functional setting
• Strong communication and influencing skills
• ability to drive alignment and resolve conflicts
• Experience working with policies, procedures, and SOPs in a regulated environment

Experience supporting programs in Obesity, Diabetes, or related metabolic diseases

• A 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
• A 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