Regulatory Affairs, Sr Manager Obesity and Related Conditions

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. United States Regulatory Senior Manager Obesity and Related Conditions Live What You Will Do Lets do this! Lets change the world! Amgen is seeking a United States Regulatory Lead (USRL) 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 regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as the U.S. regulatory lead for global programs in obesity and related cardiometabolic conditions. You will represent the U.S. on global teams, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of commercial licenses. This role requires the ability to translate scientific and clinical insights into clear, actionable regulatory strategies. Purpose: Ensure Amgen secures and maintains required U.S. licenses and authorizations to support clinical development and marketed products in compliance with regulatory requirements. People Leadership: Provides matrix and peer leadership and may directly manage regulatory leads and/or support staff, depending on level. Reporting Line: Reports to a GRL; with primary interaction within the Global Regulatory Team (GRT). Win What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Key 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 elevate 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. Basic Qualifications Doctorate degree and 2 years of regulatory experience OR Masters degree and 4 years of regulatory experience OR Bachelors degree and 6 years of regulatory experience OR Associates degree and 10 years of regulatory experience OR High school diploma / GED and 12 years of regulatory experience Demonstrated experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle. Experience contributing to regulatory strategy, including risk assessment, scenario planning, and Health Authority engagement in partnership with global leadership. Preferred Qualifications Experience supporting or leading regulatory strategy for programs in obesity, metabolic disorders, endocrinology, or related therapeutic areas. Strong scientific literacy in obesity and metabolic disease, including metabolic pathways, weight regulation biology, and relevant clinical endpoints (e.g., weight loss, cardiovascular outcomes, metabolic biomarkers). Experience leading U.S. labeling strategy, including negotiation and timeline management in a cross-functional environment. Strong communication and influencing skills, with the ability to drive alignment and resolve conflicts. Experience supporting regulatory submissions or Health Authority interactions outside the U.S. in collaboration with global teams is a plus. Experience working with policies, procedures, and SOPs in a regulated environment Thrive What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include 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. Refer to the Work Location Type in the job posting to see if this applies. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #J-18808-Ljbffr BioSpace