Amgen

Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $189,632 - $256,561 per year

Job Level

Senior

About the role

  • The Director, Global Regulatory Lead (GRL) provides strategic regulatory leadership for programs focused on obesity and related cardiometabolic conditions.
  • 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.
  • Develop and lead global regulatory strategy for obesity and metabolic disease programs with focus on Type II diabetes.
  • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations.
  • Lead the creation of the Global Regulatory Strategic Plan (GRSP), including risk assessment and regulatory scenario planning.
  • Advise on key clinical development elements relevant to obesity programs.
  • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
  • Oversee execution of major global regulatory submissions, including clinical trial applications and marketing applications.
  • Lead strategy development and preparation for key Health Authority interactions related to metabolic disorders.
  • Build, mentor, and support high-performing global regulatory teams.

Requirements

  • 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
  • 8–10+ 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.
Benefits
  • 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
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategyglobal submissionsclinical trial applicationsmarketing applicationsrisk assessmentregulatory scenario planningreal-world evidence strategylong-term outcome measureschronic disease regulatory considerationsscientific literacy
Soft Skills
leadershipcommunicationnegotiationmentoringteam buildinginfluencingguiding teamsstrategic decision-makingcross-functional collaborationproblem-solving
Certifications
Doctorate degreeMaster’s degreeBachelor’s degree