Director, Regulatory Affairs EU

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<p><strong>About this role</strong></p><p>TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.</p><p>The Director, Regulatory Affairs, EU is responsible for leading and executing regional and global regulatory strategies to support drug and device development. This role ensures compliance with European and international regulations while enabling efficient clinical development and successful project delivery.</p><p>As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.</p><p><strong>Key Responsibilities</strong></p><ul><li><p><span>Lead and Support European and global regulatory strategy support for the Business Units and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations</span></p></li><li><p><span>European and global support of the strategy teams at the Business Units to develop a Regulatory and Startup strategy for new device, drug and combination products focused on RFPs and Projects</span></p></li><li><p><span>Developing regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetings</span></p></li><li><p><span>Lead and support regulatory development support activities including Pediatric Investigation Plans, Orphan Designation and other designations/support (e.g., PRIME)</span></p></li><li><p><span>Regulatory Support of capabilities and bid defense meetings</span></p></li></ul><p><strong>Qualifications</strong></p><ul><li><p>Advanced degree in Life Sciences, Pharmacy, Medicine, or a related field</p></li><li><p>Significant experience in regulatory affairs within pharmaceutical, biotechnology, or CRO environments</p></li><li><p>Strong knowledge of European regulatory requirements and experience with EMA and national authorities</p></li><li><p>Proven ability to lead regulatory strategy and work effectively with cross-functional and global teams</p></li><li><p>Excellent communication, organizational, and problem-solving skills<br></p></li></ul><p><strong>What We Offer</strong></p><p>We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.</p><p>Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.</p><p><strong>A Bit More About Us</strong></p><p>Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.</p><p></p><p></p>