Director, Global Regulatory Affairs – Cardiometabolic Disorders

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $195.6k - $264.7k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

🎯 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 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

🏖️ Benefits

• 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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