HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
OR
United States Regulatory Lead -Obesity and Related Conditions
Live
What you will do
Let's do this! Let's change the world!
Amgen is seeking a United States Regulatory Lead (USRL) 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 standards-with 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 grade).
Reporting line: Reports to a Global Regultory Lead (GRL); based in the assigned region with interaction primarily on the Global Regulatory Team (GRT).
Win
What we expect of you
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.
Key responsibilities
Execute the approved U.S. regulatory strategy for assigned programs and represent the region on global governance teams (e.g., GRT; may include GDT/CST/LWG as applicable).
Plan and lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans, U.S. regulatory requirements, and Amgen standards.
Lead U.S. regulatory document development, including labels, briefing packages, and key submission components consistent with product strategy.
Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group (LWG), including negotiation approach, timelines, and deviation/waiver decisions as applicable.
Provide regulatory direction on U.S. mechanisms and pathways tooptimizedevelopment (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable).
Lead Health Authority interactions for assigned products: build relationships, prepare/lead engagements, and document/communicate outcomes to GRT and senior management.
Manage Responses to Questions (RTQs) and other agency feedback by coordinating cross-functional inputs, driving alignment, and ensuringtimely, high-quality responses.
Assess regulatory risk and likelihood of success; communicate scenarios, expectations, and contingencies to GRT and line management.
Ensure ongoing regulatory compliance for assigned products (e.g., commitments, obligations, regulatory history/record accuracy) and escalate issues proactively.
Maintain and apply U.S. regulatory intelligence:monitorevolving legislation/guidance and assess/communicate impact (including competitor labeling where relevant).
Partner with cross-functional teams (Clinical, Medical, Safety, Commercial) to ensure strategy alignment, including support for U.S. promotional/data applicability considerations as needed.
If applicable, lead and develop staff through clear prioritization, coaching, and resource planning to meet programobjectives.
Basic Qualifications:
Doctorate degree and 2 years ofdirectly relatedexperience OR
Master's degree and 6 years ofdirectly relatedexperience OR
Bachelor's degree and 8 years ofdirectly relatedexperience OR
Associate's degree and 10 years ofdirectly relatedexperience
Preferred Qualifications:
Regulatory submissions experience anddemonstratedexperienceinteracting with regulatory agencies(FDA)
Strong knowledge of theU.S. regulatory environmentand drug development lifecycle
Experience developing/implementing regulatory strategy, includingrisk management and contingency planning
Experience leading U.S. labeling strategy, negotiation, and timeline management in a cross-functional setting
Strong communicationand influencing skills; ability to drive alignment and resolve conflicts
Experience working with policies, procedures, and SOPs in a regulated environment
Experience supporting programs inObesity, Diabetes, or related metabolic diseases
Thrive
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.
