Regulatory Submissions Manager – EMEA

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🔥 13 hours ago

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Fortrea

WebsiteLinkedInAll Job Openings

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 for designated projects within Site Readiness. • Coordinate responses to queries ensuring required timelines are met. • Provides consolidated country requirements and regular status updates to project team and Client, as applicable. • Responsible for ensuring the compliance of deliverables to applicable regulations, guidance requirements and client requests. • Evaluate the impact of clinical/regulatory changes on assigned projects as well as overall business operations. • Liaise with and/or support local teams to liaise with RA, IRB/EC, and Third Bodies on behalf of clients. • Manage applicable user access to CTIS and act as a backup in case of unexpected absences of other team members. • Ensure responsible deliverables are met within required timelines maintaining awareness of Green Light (GL) approval and Site Ready to Enroll (RTE) milestones. • Proactively identifying and escalating to Start-up Lead any risk to meeting deliverables. • Support audits (internal and external) and inspections, as needed. • Support resolution of any findings.

🎯 Requirements

• Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification. • Understanding of and ability to determine relevance of governmental regulatory processes and regulations as they pertain to investigational drug regulations. • Minimum of 5 years’ experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development. • Excellent communication, organization, and planning skills with an attention to detail. • Direct supervisory and project management skills and ability to work independently.

🏖️ Benefits

• N/A