Senior Regulatory Affairs Manager – Obesity and Related Conditions

🕒 Abril 2

🌽 Illinois, Washington – Remoto

🌽 Illinois – Remote ☕ Washington – Remote

💵 $153.935 - $184.298 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Biotechnology • Pharmaceuticals • Science

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 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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