Global Regulatory Affairs Director, Obesity and Related Conditions

• 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)
• Advises on key clinical development elements relevant to obesity programs
• Lead the Global Regulatory Team (GRT) and represent GRAAS on cross-functional teams
• Partner closely with Clinical Development, Safety, CMC, Value & Access, Commercial, and regional regulatory colleagues
• Oversee execution of major global regulatory submissions
• Ensure consistency, scientific rigor, and clarity across core regulatory documents
• Guides the regulatory interpretation of evolving FDA/EMA guidance
• Lead strategy development, preparation, and cross-functional alignment for key Health Authority interactions
• Represent Amgen in external alliances, consortia, scientific policy discussions, and trade associations
• Build, mentor, and support high-performing global regulatory teams
• Foster an inclusive, collaborative environment
• Develop regulatory talent with expertise in metabolic disease science, regulatory strategy, and global execution

• Doctorate degree and 5 years of regulatory experience in biotech or science
• Master’s degree and 8 years of regulatory experience in biotech or science
• Bachelor’s degree and 10 years of regulatory experience in biotech or science
• 8–10+ years of global regulatory experience, with demonstrated leadership of regulatory strategy for programs in 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

Experience in real-world evidence strategy, long-term outcome measures, and chronic disease regulatory considerations

• 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, and flexible spending accounts
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible