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

Amgen•Thousand Oaks, CA

2d•$83,975 - $113,613

About The Position

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.

Requirements

Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum
Bachelor’s degree in a science discipline (biology, life science, health science) and 2 years of directly related experience
Associate’s degree in a science discipline (biology, life science, health science) and 6 years of directly related experience
High school diploma / GED in a science discipline (biology, life science, health science) and 8 years of directly related experience

Nice To Haves

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

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.