Fortrea
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
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
Job not on LinkedIn
🕒 June 25
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Fortrea
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
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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