Senior Associate - United States Regulatory Professional – Obesity and Related Conditions

Career Category Regulatory Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Associate, United States Regulatory Professional – Obesity and Related Conditions What you will do Let’s do this. Let’s change the world. Amgen is seeking a United States Regulatory Professional (USRP) supporting products in the Obesity and Related Conditions Therapeutic Area (TA). Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of Amgen molecules. In this product-facing role, you will support the creation and submission of regulatory documents under the supervision of a more experienced regulatory lead. The USRP provides operational support for U.S. regulatory execution by coordinating submission deliverables, maintaining compliant documentation, and partnering cross-functionally to enable effective health authority engagement. Key responsibilities Coordinate and execute U.S. regulatory submissions in compliance with Amgen corporate standards and FDA requirements. Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time. Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications. Create and maintain product regulatory history documentation (e.g., IMR, as applicable). Support U.S. labeling activities, including review of source text to enable U.S. labeling updates. Support review of promotional and non-promotional materials as applicable and in accordance with internal requirements. Coordinate and QC briefing documents and other materials for meetings with regulatory agencies. Under general supervision, support FDA interactions and act as a point of contact as appropriate to fulfill product-specific obligations. Support responses to health authority questions by coordinating inputs, tracking actions, and ensuring document readiness. Collate and communicate regulatory information across regulatory colleagues and cross-functional teams; provide timely updates on U.S.-specific considerations. Maintain awareness of emerging U.S. legislation, guidance, and regulatory policy; escalate and disseminate relevant updates to appropriate stakeholders. Participate in cross-functional and team governance (e.g., GRT support including agendas/minutes) as needed. What expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a self-starter with these qualifications. Basic Qualifications: Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum OR Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience OR Associate’s degree in a science discipline (biology, life science, health science) and 6 years of directly related experience OR High school diploma / GED in a science discipline (biology, life science, health science) and 8 years of directly related experience Preferred Qualifications: Experience in a regulated industry (e.g., biotech/pharma, medical device, clinical research, healthcare) Experience supporting programs in Obesity, Diabetes, or related metabolic diseases through scientific or clinical work Strong written and oral communication skills Strong organizational skills; ability to manage multiple activities, timelines, and stakeholders Demonstrated attention to detail and document quality mindset Ability to identify, communicate, and escalate risks/issues appropriately Experience with document management and archiving practices in a regulated setting 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, we’ll 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. #obesity . Salary Range 83,974.90USD -113,613.10 USD