Diagnostic Regulatory Affairs Manager

March 18

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Amgen

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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.

Biologics • Human therapeutics • Development of novel products

10,000+ employees

Founded 1980

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 Post-IPO Debt on 2022-12

📋 Description

• In this vital role, you will support establishing sustainable processes and delivering strategic outcomes. • You will develop and implement regulatory strategies for in vitro diagnostics (IVDs) and companion diagnostics (CDx’s). • Providing critical strategic and tactical IVD/CDx regulatory guidance. • Develop clinical and commercial regulatory strategies. • Handle interactions with diagnostic partners. • Prepare for and conduct meetings with regulatory agencies. • Review key diagnostic regulatory submissions to health authorities. • Assess relevant drug and IVD/CDX regulations impact on development activities. • Manage Regulatory Information Management System and support document management.

🎯 Requirements

• Must have in-depth knowledge of regulatory document management systems like VeevaVault. • Doctorate degree or Master’s degree and 3 years of Health Agency or Med-Device or Regulatory experience or Bachelor’s degree and 5 years of same experience or Associate’s degree and 10 years of same experience or High school diploma / GED and 12 years of same experience. • Preferred: MS Degree in Regulatory Affairs, Life Sciences, or Engineering, 6 plus years of experience in Regulatory Affairs including US and international medical device and/or IVD/CDx regulations, 8 plus years of experience in the medical device and/or IVD/CDx industry.

🏖️ Benefits

• Comprehensive employee benefits package including medical, dental and vision coverage. • Retirement and Savings Plan with generous contributions. • Life and disability insurance and flexible spending accounts. • A discretionary annual bonus program or sales-based incentive plan. • Stock-based long-term incentives. • Award-winning time-off plans and bi-annual company-wide shutdowns. • Flexible work models, including remote work arrangements where possible.