Director, Global Regulatory Affairs – Cardiometabolic Disorders

1001 Amgen Inc.; Thousand Oaks (CA); Hybrid; USD 196,000 - 265,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Medical, Dental, Vision benefits

Stock-based long-term incentives

Time-off plans

Job summary

Amgen Inc. is seeking a Director of Global Regulatory Affairs for Cardiometabolic Disorders. You will lead global regulatory strategy for obesity and metabolic disease programs, coordinating cross-functional teams and ensuring robust regulatory submissions.

The role requires deep scientific understanding and proactive engagement with health authorities. You will oversee global submissions, labeling updates, and interactions with FDA/EMA, shaping long-term regulatory strategies and risk-benefit

Qualifications

• Doctorate or Master’s with multiple years of regulatory experience.
• Experience leading regulatory strategy for obesity/metabolic programs.
• Proven ability to interact with FDA, EMA and other bodies.

Responsibilities

• Develop and lead global regulatory strategy for obesity and metabolic disease programs.
• Lead interactions with Health Authorities and external partners.
• Oversight of major global regulatory submissions and labeling updates.

Skills

Strong communication and negotiation

Regulatory leadership

Global regulatory experience

Education

Doctorate degree with regulatory experience

Master’s degree with regulatory experience

Bachelor’s degree with regulatory experience

Job description

Career Category Regulatory Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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 Let’s do this. Let’s change the world. The Global Regulatory Affairs Director provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions—a 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 programs—study 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 risk–benefit 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 documents—especially 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., benefit–risk 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

Basic Qualifications

• Doctorate degree and 4 years of regulatory experience OR Master’s degree and 7 years of regulatory experience OR Bachelor’s degree and 9 years of regulatory experience

Preferred Qualifications

• 8–10+ 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

• Salary Range 195,640.25USD -264,689.75 USD
• 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.

Sponsorship for this role is not guaranteed.

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.

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen