Director, Global Regulatory Affairs – Cardiometabolic Disorders

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and spearhead global regulatory strategies for programs related to obesity and metabolic diseases.

• Integrate clinical, nonclinical, CMC, and safety data into regulatory guidance.

• Lead the formulation of the Global Regulatory Strategic Plan, encompassing risk assessment and regulatory scenario analysis.

• Provide insights on clinical development components, including study designs, chronic treatment safety, cardiovascular outcomes, biomarkers, pediatric development, and real-world evidence strategies.

• Head the Global Regulatory Team and represent Global Regulatory Affairs and Strategy in cross-functional initiatives.

• Collaborate with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory partners.

• Convert intricate metabolic science into implementable regulatory strategies.

• Supervise significant global regulatory submissions, such as clinical trial applications, marketing submissions, pediatric plans, and labeling revisions.

• Ensure consistency, scientific rigor, and clarity across essential regulatory documents.

• Guide the regulatory interpretation of evolving FDA and EMA guidelines.

• Lead strategic alignment for interactions with Health Authorities, including the FDA, EMA, PMDA, NMPA, and other organizations.

• Represent Amgen in external partnerships, consortia, scientific policy discussions, and trade associations.

• Anticipate perspectives of Health Authorities and prepare teams for critical discussions.

• Build, mentor, and support high-achieving global regulatory teams.

• Promote an inclusive, collaborative environment and nurture regulatory talent.

⛳️ Requirements

• Doctorate degree with 4 years of regulatory experience OR Master’s degree with 7 years of regulatory experience OR Bachelor’s degree with 9 years of regulatory experience.

• Preferred 8–10+ years of global regulatory experience.

• Leadership experience in regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas is preferred.

• Strong scientific understanding of metabolism, energy balance physiology, hormone signaling pathways, adiposity biology, and relevant clinical endpoints.

• Experience in developing global submissions and leading interactions with FDA, EMA, and other regulatory authorities.

• Proven success in leading Global Regulatory Teams and influencing governance bodies on complex regulatory and clinical development matters.

• Capability to translate metabolic science into clear regulatory strategies and decision-making frameworks.

• Excellent communication and negotiation abilities.

• Experience in real-world evidence strategies, long-term outcome measures, and chronic disease regulatory considerations is advantageous.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision insurance.

• Life and disability coverage.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work arrangements where feasible.

• Opportunities for career development.

• Support for work/life balance.