Director, Regulatory Affairs EU

Job description

About this role 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. 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. 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. Key Responsibilities: 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 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 p...