Senior Associate - United States Regulatory Professional – Obesity and Related C
Amgen
Job Description
<h3><b>Career Category</b></h3>Regulatory<h3><b>Job Description</b></h3><h3>Join <a href="https://himalayas.app/companies/amgen">Amgen</a>’s Mission of Serving Patients</h3><p>At <a href="https://himalayas.app/companies/amgen">Amgen</a>, 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.</p><p>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. <a href="https://himalayas.app/companies/amgen">Amgen</a> 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 <a href="https://himalayas.app/companies/amgen">Amgen</a> 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.</p><p>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 <a href="https://himalayas.app/companies/amgen">Amgen</a> team. Join us and transform the lives of patients while transforming your career.</p><h3><b>Senior Associate, United States Regulatory Professional – Obesity and Related Conditions</b></h3><h3><b>What you will do</b></h3><p>Let’s do this. Let’s change the world. <a href="https://himalayas.app/companies/amgen">Amgen</a> 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 <a href="https://himalayas.app/companies/amgen">Amgen</a> 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.</p><p>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.</p><h3>Key responsibilities</h3><ul>
<li>Coordinate and execute U.S. regulatory submissions in compliance with <a href="https://himalayas.app/companies/amgen">Amgen</a> corporate standards and FDA requirements.</li>
<li>Drive submission readiness by coordinating inputs, tracking timelines, and ensuring deliverables are complete, accurate, and submitted on time.</li>
<li>Maintain regulatory documentation and records, including preparation, delivery, and electronic archiving of submission content and agency communications.</li>
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