Global Regulatory Affairs Director, Obesity and Related Conditions

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

If you feel like youre part of something bigger its because 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 over 10 million patients worldwide. Its time for a career you can be proud of.

Global Regulatory Lead - Obesity and Related Conditions

Live

What you will do

Lets do this! Lets change the world!

Amgen is seeking a Global Regulatory Director to provide strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditionsa rapidly evolving therapeutic area requiring sophisticated scientific clinical and regulatory assessment. The GRL is 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 onkey clinical development elements relevant to obesity programsstudy designs chronic treatment safety cardiovascular outcomes evaluation metabolic biomarker selection pediatric development and real-world evidenceplans.

Cross-Functional Influence & Enterprise Collaboration

• Lead the Global Regulatory Team (GRT)and represent GRAAS on cross-functional teams ( Team Evidence Generation Team Global SafetyTeametc.).

• 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 partnersfacilitatingalignment 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 metabolic disorders 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 withexpertisein metabolic disease science regulatory strategy and global execution.

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.

Basic Qualifications:

Doctorate degree and 5 years of regulatory experience in biotech or science

OR

Masters degree and 8 years of regulatory experience in biotech or science

OR

Bachelors degree and 10 years of regulatory experience in biotech or science

Preferred Qualifications:

• 810 years of global regulatory experience withdemonstratedleadership 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 communicationand 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.

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.

#Obesity

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