[Hiring] Director, Global Regulatory Affairs – Cardiometabolic Disorders @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. 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.
  • Integrate clinical, nonclinical, CMC, and safety evidence into cohesive regulatory recommendations.
  • Lead the creation of the Global Regulatory Strategic Plan (GRSP).
  • Advise on key clinical development elements relevant to obesity programs.
• Cross-Functional Influence & Enterprise Collaboration
  • Lead the Global Regulatory Team (GRT) and represent Global Regulatory Affairs and Strategy (GRAAS) on cross-functional teams.
  • Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues.
  • Translate complex metabolic science into actionable regulatory strategy for cross-functional partners.
• Regulatory Execution & Documentation Excellence
  • Oversee execution of major global regulatory submissions.
  • Ensure consistency, scientific rigor, and clarity across core regulatory documents.
  • Guide the regulatory interpretation of evolving FDA/EMA guidance.
• HA & External Stakeholder Engagement
  • Lead strategy development and preparation for key Health Authority interactions.
  • Represent Amgen in external alliances, consortia, and scientific policy discussions.
  • Anticipate HA perspectives informed by precedent in the obesity space.
• People Leadership, Team Performance & Cultural Agility
  • Build, mentor, and support high-performing global regulatory teams.
  • Foster an inclusive, collaborative environment.
  • Develop regulatory talent with expertise in metabolic disease science.

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

Requirements

• 8–10+ years of global regulatory experience.
• Strong scientific literacy in metabolism and related fields.
• Experience developing global submissions and leading interactions with regulatory bodies.
• Demonstrated success leading GRTs and influencing governance bodies.
• Proven ability to translate metabolic science into regulatory strategy.
• Strong communication and negotiation skills.
• Experience in real-world evidence strategy is a plus.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan.
• Group medical, dental and vision coverage.
• Life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Company Description

Amgen is dedicated to improving the quality of life for people around the world and fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values.