Senior Regulatory Affairs Manager – Obesity and Related Conditions
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Job Description
U.S. Regulatory Lead developing and executing regulatory strategies for obesity and related conditions at Amgen. Collaborating with global teams to meet regulatory requirements and maintain licenses.
Responsibilities:
- Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL), serving as the U.S. regulatory lead for global programs in obesity and related cardiometabolic conditions.
- Represent the U.S. on global teams, contribute to global regulatory and clinical development strategies, and support the acquisition and maintenance of commercial licenses.
- Ensure Amgen secures and maintains required U.S. licenses and authorizations to support clinical development and marketed products in compliance with regulatory requirements.
- Lead U.S. regulatory submissions (e.g., clinical trial and marketing applications) in alignment with global filing plans and regulatory requirements.
- Monitor and apply U.S. regulatory intelligence, including evolving legislation, guidance, and relevant competitor activity.
Requirements:
- Doctorate degree and 2 years of regulatory experience OR Master’s degree and 4 years of regulatory experience OR Bachelor’s degree and 6 years of regulatory experience OR Associate’s degree and 10 years of regulatory experience OR High school diploma / GED and 12 years of regulatory experience
- Demonstrated experience with U.S. regulatory submissions and direct FDA interaction, with strong knowledge of the U.S. regulatory environment and drug development lifecycle.
- Experience contributing to regulatory strategy, including risk assessment, scenario planning, and Health Authority engagement in partnership with global leadership.
Benefits:
- 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
- flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
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