Regulatory Affairs Manager – US Regulatory Lead, Rare Disease

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $112.744 - $152.536 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

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

• Support the Global Regulatory Team in US Regulatory Activities, including IND development and submission • Act as the point of contact with regulatory agencies • Provide guidance on local mechanisms to optimize product development and regulatory approvals • Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements • Ensure and support local regulatory product compliance, including agency commitments • Develop and maintain local labels in line with local legislation and Amgen standards and procedures • Support and provide input into global regulatory strategy for assigned products, including Global Regulatory Plans and labeling documents • Prepare supportive documentation for regulatory deliverables, such as regulatory landscapes or research for regulatory strategy and target product labels • Manage the process for responding to regulatory agency questions • Provide primary authorship to routine regulatory correspondence • Work with federal, state, and local regulatory agencies on issues and regulations affecting Amgen’s products and services

🎯 Requisitos

• Doctorate degree OR Master’s degree and 2 years of Regulatory Affairs experience OR Bachelor’s degree and 4 years of Regulatory Affairs experience OR Associates degree and 8 years of Regulatory Affairs experience OR High school diploma / GED and 10 years of Regulatory Affairs experience • Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum • Regulated industry, science or clinical practice experience • Organizational skills; detail oriented and able to deal with frequent changes in product activity

🏖️ Benefícios

• A 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 • Financial plans with opportunities to save towards retirement or other goals

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