Fortrea
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
Regulatory Manager
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🔥 0 minutes ago
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Fortrea
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
📋 Description
• Collaborate with peers across the organization to achieve client-centric delivery in a matrix organization. • Oversight and accountability of Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC) and Third Body submissions • Manage projects according to the billing guide to ensure the work is performed within budget. • Initiate improvements to enhance the efficiency and the quality of the submission work performed on assigned projects. • Support audits (internal and external) and inspections, as needed.
🎯 Requirements
• Bachelor’s Degree in Life Sciences or equivalent • Minimum 4 years of experience in the Pharmaceutical/CRO industry in Regulatory Affairs or Drug Development
🏖️ Benefits
• Global travel required 5% of the time, which will require an overnight stay • Some flexibility in scheduling may be required
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