Regulatory Strategy Associate

🔥 12 hours ago

🏄 California, Massachusetts – Remote

🏄 California – Remote 🍂 Massachusetts – Remote

💵 $71k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🦅 H1B Visa Sponsor

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Premier Research

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Venture Round on 2016-10

Biotechnology • Healthcare Insurance • Pharmaceuticals

Premier Research is a company dedicated to helping biotech companies transform groundbreaking scientific ideas into life-changing medical treatments. They specialize in clinical research and development, product development and regulatory consulting, and offer expertise in areas such as oncology, hematology, rare diseases, cell and gene therapy, and pediatrics, among others. Premier Research is committed to boosting clinical development strategies and guiding innovations from molecule to market. They provide a range of services that support biotech firms in navigating the complex path to medical approval, with a focus on rare diseases and innovative therapies.

📋 Description

• Independently prepare IND Modules for routine submissions • Support regulatory affairs leadership in preparation of complex submissions • Perform thorough independent background research through all pertinent search engines • Ensure that documents appropriately evaluate and present data and methodology • Navigate and obtain information for projects from all available resources • Produce timely, scientifically accurate data summaries • Construct documents in a manner consistent with applicable regulations and guidance • Serve as Regulatory representative in department discussions • Interface with international affiliates on regional regulatory strategy

🎯 Requirements

• Master’s degree or international equivalent in a science or health related field; PhD or PharmD preferred • 3+ years of experience working in a CRO, pharmaceutical biotechnology, consulting, regulatory affairs, or device/diagnostics industry • Strong scientific verbal and writing skills • Excellent organizational, writing, communication and time management skills • Ability to communicate and interact effectively within the department, across departments and on project team(s)

🏖️ Benefits

• health insurance • retirement plans • paid time off