Senior Regulatory Affairs Manager – Obesity and Related Conditions

🕒 April 2

🌽 Illinois, Washington – Remote

🌽 Illinois – Remote ☕ Washington – Remote

💵 $153.9k - $184.3k / year

⏰ Full Time

🟠 Senior

🚔 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 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