Job Details Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. United States Regulatory Strategy, Obesity and Related Conditions, Manager What you will do Lets do this. Lets change the world. In this vital role you will. 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 standardswith a strong focus on regulatory compliance and patient safety.

Purpose:

Ensure Amgen acquires and maintains required U.S. licenses/authorizations to support clinical trials and maintain marketed products, while ensuring regulatory compliance with a focus on patient safety.

People leadership:

This role provides matrix/peer leadership and may directly manage one or more regulatory leads and/or support staff (dependent on role need/grade).

Reporting line:

Based in the assigned region with interaction primarily on the Global Regulatory Team (GRT); reports to Global Regulatory Lead (GRL). What we expect of you We are all different, yet we all use our unique contributions to serve patients. 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. Responsibilities 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).

Basic Qualifications:

Doctorate degree OR Masters degree and 2 years of regulatory affairs experience OR Bachelors degree and 4 years of regulatory affairs experience OR Associates degree and 8 years of regulatory affairs experience OR High school diploma / GED and 10 years of regulatory affairs experience

Preferred Qualifications:

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 you can expect from 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. Apply now and make a lasting impact with the Amgen team. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States