Regulatory Affairs, Sr Manager – Obesity and Related Conditions

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyou’repart of something bigger,it’sbecause 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 over10 million patientsworldwide.It’stime for a career you can be proud of. 

OR

United States RegulatoryLead–Obesity and Related Conditions 

Live

What you will do

Let’sdo this!Let’schange 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 Amgenacquiresandmaintainsrequired U.S. licenses/authorizations to support clinical trials andmaintainmarketed products, while ensuring regulatory compliance with a focus on patient safety.

Peopleleadership: 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 aGlobalRegultoryLead (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 weseekis 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 relatedexperienceOR

• Master’s degree and 6 years ofdirectly relatedexperienceOR

• Bachelor’s degree and 8 years ofdirectly relatedexperienceOR

• 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 eligibi