Career CategoryRegulatory
Job DescriptionSenior Associate, United States Regulatory Professional - Obesity and Related ConditionsWhat you will doLet'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 youWe 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 usAs 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.comSalary Range83,974.90USD -113,613.10 USD
