Director, Global Regulatory Affairs – Cardiometabolic Disorders

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.640 - $264.689 / ano

⏰ Tempo Integral

🔴 Especialista

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Develop and lead global regulatory strategy for obesity and metabolic disease programs • Integrate clinical, nonclinical, CMC, and safety evidence into regulatory recommendations • Lead creation of the Global Regulatory Strategic Plan, including risk assessment and regulatory scenario planning • Advise on clinical development elements including study designs, chronic treatment safety, cardiovascular outcomes, biomarkers, pediatric development, and real-world evidence plans • Lead the Global Regulatory Team and represent Global Regulatory Affairs and Strategy on cross-functional teams • Partner with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues • Translate complex metabolic science into actionable regulatory strategy • Oversee major global regulatory submissions, including clinical trial applications, marketing applications, pediatric plans, and labeling updates • Ensure consistency, scientific rigor, and clarity across core regulatory documents • Guide regulatory interpretation of evolving FDA and EMA guidance • Lead strategy and alignment for Health Authority interactions with FDA, EMA, PMDA, NMPA, and other bodies • Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations • Anticipate Health Authority perspectives and prepare teams for high-stakes discussions • Build, mentor, and support high-performing global regulatory teams • Foster an inclusive, collaborative environment and develop regulatory talent

🎯 Requisitos

• 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 preferred • Leadership of regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas preferred • 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 Global Regulatory Teams and influencing governance bodies on complex regulatory and clinical development issues • Ability to translate metabolic science into clear regulatory strategy and decision-making frameworks • Strong communication and negotiation skills • Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations is a plus

🏖️ Benefícios

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support

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