Global Regulatory Affairs Director, Obesity and Related Conditions
BioSpace, Washington, District of Columbia, United States
Global Regulatory Lead - Obesity and Related Conditions
Amgen is seeking a Global Regulatory Director to provide strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions, a rapidly evolving therapeutic area requiring sophisticated scientific, clinical, and regulatory assessment. The Global Regulatory Lead 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.
What You Will Do We’re looking for a visionary leader ready to drive our regulatory strategy and execution for obesity and related cardiovascular conditions.
Key Responsibilities
Develop and lead the 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.
Advise 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 and represent GRAAS on cross‑functional teams (e.g., Indication Team, Evidence Generation Team, Global Safety Team).
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.
Guide 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 Health Authority 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 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.
Masters degree and 8 years of regulatory experience in biotech or science.
Bachelor’s degree and 10 years of regulatory experience in biotech or science.
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 regulatory teams 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, we support your journey every step of the way.
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.
careers.amgen.com
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.
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
#J-18808-Ljbffr
What You Will Do We’re looking for a visionary leader ready to drive our regulatory strategy and execution for obesity and related cardiovascular conditions.
Key Responsibilities
Develop and lead the 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.
Advise 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 and represent GRAAS on cross‑functional teams (e.g., Indication Team, Evidence Generation Team, Global Safety Team).
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.
Guide 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 Health Authority 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 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.
Masters degree and 8 years of regulatory experience in biotech or science.
Bachelor’s degree and 10 years of regulatory experience in biotech or science.
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 regulatory teams 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, we support your journey every step of the way.
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.
careers.amgen.com
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.
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
#J-18808-Ljbffr