EU Director – Regulatory Affairs

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🔥 0 minutes ago

🌐 United Kingdom, Spain, +3 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇸🇪 Sweden – Remote 🇩🇪 Germany – Remote 🇵🇹 Portugal – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Lead and support European and global regulatory strategy for Business Units • Support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations • Develop regulatory and startup strategies for new device, drug and combination products • Set up and maintain country regulatory and startup intelligence • Develop regulatory documents and lead support for EMA and European national scientific advice and protocol assistance meetings • Lead and support regulatory development activities, including Pediatric Investigation Plans, orphan designation and other designations such as PRIME • Support setup of new systems for startup • Support regulatory capabilities and bid defense meetings • Collaborate with USA regulatory teams to develop global regulatory strategies and provide regulatory guidance • Collaborate and communicate with other clinical development departments at TFS • Support development of new processes and procedures • Identify and develop strategic initiatives, including process improvements • Interact with senior management across disciplines • Ensure compliance with TFS SOPs, guidelines, local laws and regulations

🎯 Requirements

• Bachelor’s Degree, preferably in life science • 9+ years of relevant experience • Experience with international regulatory strategy, guidance and support for multi-national clinical trials, particularly with EU CTR and CTIS • Experience with supporting European scientific advice, orphan designation and pediatric investigation plans • Accustomed to supporting request for proposal and budget reviews, capabilities and bid defence meetings for international customers • Able to work in a fast-paced environment with changing priorities • Understand the basic terminology and science associated with the assigned drugs • Previous experience with supporting and attending European scientific advice meetings and similar agency interactions

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative and innovative work environment • Opportunity to make a difference in patients’ lives