Director, Global Regulatory Affairs Cardiometabolic Disorders

BioSpace; Washington (District of Columbia); On-site; USD 190,000 - 300,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen seeks a Director of Global Regulatory Affairs Cardiometabolic Disorders to lead regulatory strategy for obesity and related metabolic programs. You will drive global submissions, advise on study designs, safety assessments, and labeling decisions, and engage with health authorities worldwide.

This role requires leadership across Clinical Development, Safety, CMC, and Commercial teams. You will shape regulatory pathways, develop strategic plans, and ensure regulatory excellence across

Qualifications

• Doctorate/Masters/Bachelors with regulatory experience

Responsibilities

• Develop and lead global regulatory strategy for obesity and metabolic programs.
• Lead interactions with FDA/EMA and other authorities.
• Oversee major global regulatory submissions and labeling updates.
• Mentor Global Regulatory Team and partner with cross-functional functions.

Skills

Regulatory leadership

Global regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director, Global Regulatory Affairs Cardiometabolic Disorders

What you will do

Lets do this. Lets change the world. The Global Regulatory Affairs Director provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditionsa rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. You will be accountable for developing and executing global regulatory strategies, shaping cross-functional decision-making, and leading global interactions with Health Authorities and external partners. This role ensures regulatory strategies fully reflect the unique scientific, mechanistic, and clinical complexities of metabolic disorders.

Key Responsibilities

Regulatory Strategy & Scientific Leadership

Develop and lead global regulatory strategy for obesity and metabolic disease programs, grounded in a strong understanding of metabolic biology, endocrine pathways, adiposity-related physiology, and cardiometabolic risk science.

Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations, accounting for regulatory precedent in obesity and related conditions.

Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment, regulatory scenario planning, and evaluation of novel/expedited pathways.

Advises on key clinical development elements relevant to obesity programsstudy designs, chronic treatment safety, cardiovascular outcomes evaluation, metabolic biomarker selection, pediatric development, and real-world evidence plans.

Cross-Functional Influence & Enterprise Collaboration

Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams (e.g. Indication Team, Evidence Generation Team, Global Safety Team etc.).

Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues to ensure seamless strategy execution.

Translate complex metabolic science into actionable regulatory strategy for cross-functional partners, facilitating alignment on riskbenefit thinking and long-term labeling strategy.

Regulatory Execution & Documentation Excellence

Oversee execution of major global regulatory submissions, including clinical trial applications, initial and supplemental marketing applications, pediatric plans, and labeling updates relevant to obesity programs.

Ensure consistency, scientific rigor, and clarity across core regulatory documentsespecially TPL, CDS, and briefing materials.

Guides the regulatory interpretation of evolving FDA/EMA guidance related to obesity and related conditions (where applicable).

HA & External Stakeholder Engagement

Lead strategy development, preparation, and cross-functional alignment for key Health Authority interactions (FDA, EMA, PMDA, NMPA, etc.) related to obesity and other cardiometabolic indications, including protocol advice, CV safety considerations, efficacy endpoints, long-term safety monitoring, and pediatric/labeling discussions.

Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations focused on obesity, metabolic disease, or cardiometabolic health.

Anticipate HA perspectives informed by precedent in the obesity space (e.g., benefitrisk expectations, CV outcomes requirements, weight-loss durability concerns) and prepare teams for high-stakes discussions.

People Leadership, Team Performance & Cultural Agility

Build, mentor, and support high-performing global regulatory teams.

Foster an inclusive, collaborative environment that encourages diverse perspectives, scientific rigor, and healthy debate.

Develop regulatory talent with expertise in metabolic disease science, regulatory strategy, and global execution.

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.

Basic Qualifications

Doctorate degree and 4 years of regulatory experience

OR

Masters degree and 7 years of regulatory experience

OR

Bachelors degree and 9 years of regulatory experience

Preferred Qualifications

810+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas.

Strong scientific literacy in metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and associated clinical endpoints.

Experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies.

Demonstrated success leading GRTs and influencing governance bodies on complex regulatory and clinical development issues.

Proven ability to translate metabolic science into clear regulatory strategy and decision‑making frameworks.

Strong communication and negotiation skills, with the ability to guide teams through ambiguous or high‑stakes situations.

Experience in real‑world evidence strategy, long‑term outcome measures, and chronic disease regulatory considerations is a plus.

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.

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.