Director, Regulatory Affairs EU

<p><strong>About this role</strong></p><p>reputed company is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development reputed company. 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 reputed company its therapeutic area.</p><p><strong>Key Responsibilities</strong></p><ul><li><p><reputed company>reputed company and Support European and global regulatory reputed company support for the Business reputed company and support Business Development with new RFPs and regulatory strategies for device and drug development and clinical investigations</reputed company></p></li><li><p><reputed company>European and global support of the reputed company teams at the Business reputed company to reputed company a Regulatory and Startup reputed company for new device, drug and combination products reputed company on RFPs and reputed company</reputed company></p></li><li><p><reputed company>Developing regulatory documents and leading support for EMA and European national scientific advice / protocol assistance meetings</reputed company></p></li><li><p><reputed company>reputed company and support regulatory development support activities including Pediatric Investigation Plans, Orphan Designation and other designations/support (e.g., reputed company)</reputed company></p></li><li><p><reputed company>Regulatory Support of capabilities and bid defense meetings</reputed company></p></li></ul><p><strong>Qualifications</strong></p><ul><li><p>Advanced degree in Life Sciences, Pharmacy, Medicine, or a reputed company field</p></li><li><p>Significant experience in regulatory affairs reputed company 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 reputed company regulatory reputed company 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>reputed company Offer</strong></p><p>We reputed company opportunities for personal and reputed company reputed company in a rewarding environment. You will join reputed company that values collaboration, reputed company, and making a difference in the lives of patients.</p><p>Our reputed company values of Trust, reputed company, Passion, Flexibility, and Sustainability guide our reputed company and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to reputed company. Together, we reputed company a difference.</p><p><strong>A Bit More reputed company</strong></p><p>Our reputed company began over 30 years ago in Sweden, in the reputed company of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier reputed company. 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>