United States Regulatory Lead – Obesity and Related Conditions TA

HOW MIGHT YOU DEFY IMAGINATION

If you feel likeyourepart of something biggeritsbecause you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over10 million patientsworldwide.Itstime for a career you can be proud of.

OR

United States RegulatoryLeadObesity and Related Conditions

Live

What you will do

Letsdo this!Letschange 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 leadershipexpertise 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 standardswith 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

• Masters degree and 6 years ofdirectly relatedexperienceOR

• Bachelors degree and 8 years ofdirectly relatedexperienceOR

• Associates 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 well 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.

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.