Regulatory Affairs Manager – US Regulatory Lead, Rare Disease

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🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $112.7k - $152.5k / 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

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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