Global Regulatory Director Lead Obesity & Related Conditions (Type II Diabetes)
BioSpace, Washington, District of Columbia, United States
Director, Global Regulatory Lead Obesity & Related Conditions
The Director, Global Regulatory Lead (GRL) 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. 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.
Key Responsibilities Regulatory Strategy & Scientific Leadership
Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, 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).
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 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.
Basic Qualifications
Doctorate degree and 4 years of regulatory experience.
Masters degree and 7 years of regulatory experience.
Bachelors degree and 9 years of regulatory experience.
Preferred Qualifications
10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, 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 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. This includes:
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.
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.
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.
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Key Responsibilities Regulatory Strategy & Scientific Leadership
Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes, 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).
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 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.
Basic Qualifications
Doctorate degree and 4 years of regulatory experience.
Masters degree and 7 years of regulatory experience.
Bachelors degree and 9 years of regulatory experience.
Preferred Qualifications
10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in Type II diabetes, 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 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. This includes:
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.
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.
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.
#J-18808-Ljbffr